Lots 60457716 and 60492624.

Orthopedic Devices

1

No

Nationwide and Australia.

Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10.

All lots.

Orthopedic Devices

1

No

Nationwide, Austria, Australia, Belgium, Canada, Finland, Germany, Greece, Korea, South Africa, Sweden, Switzerland, Taiwan and the United Kingdom.

Zimmer TM-400 Broach Handle; Part No. 96-210-10001. The product is a surgical instrument for use in conjunction with Zimmer TM-400 Trabecular Metal implants during spinal surgery. || The Broach Handle threads onto various broaches and trial implants. The handle with these broaches or trials attached is used to prepare and measure a vertebral space to accept a TM-400 Trabecular Metal implant.

L75118

Orthopedic Devices

1

No

Nationwide Distribution including AL, AZ, CA, CO, FL, MI, MN, NC, PA, OH, OK, TN, TX, WA, and WI.

TiTLE 2 Polyaxial Spinal System, Counter Torque Assembly Tool, Part ET1132-01, Zimmer, Warsaw, IN. || The Zimmer Title 2 counter torque assembly tool is a reuseable, non- implantable surgical tool that is provided as part of a the device system for use as a secondary option for compression and distraction of the construct assembly and initial tightening of set screws. The instrument is designed to provide equal torque in the opposite direction to the torque that is being applied to the cap screw during tightening.

Item No. 00-5901-032-00  Lots: 56572845 56574197 56574534 56574775 56575838 56573249 56574198 56574535 56575827 56575839 56573282 56574325 56574536 56575828 56575840 56573283 56574326 56574604 56575829 56576089 56573284 56574327 56574605 56575830 56576090 56573285 56574328 56574606 56575831 56576091 56574130 56574329 56574607 56575832 56576421 56574135 56574530 56574608 56575833 56576429 56574136 56574531 56574617 56575836 56576431 56574137 56574532 56574714 56575837 56576544 56574196 56574533 56574774

Orthopedic Devices

1

No

Worldwide Distribution-US (nationwide) including PR and the states of AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, WI, and the countries of Canada, Korea, Singapore, Australia, Japan, Malaysia, India, Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Iceland, Iran, Israel, Italy, Norway, Russian Federation, Saudi Arabia, South America, Spain, Sweden, Switzerland, United Kingdom, and United Arab Emirates.

PRI Femoral Impactor Block for knee prosthesis surgery. || Orthopedic Manual Surgical Instrument

Chisel lot number 60048084.

Orthopedic Devices

1

No

Nationwide and Canada.

Zimmer brand fracture blade plate instrument Chisel, 95 degree, small; assembly part 4705-03-10, catalog number 00-4705-003-10.

Model: Part Number 3256-01, Affected: All

Orthopedic Devices

All lot codes since 1998; Catalog Number 8000-3303

Orthopedic Devices

1

No

Products were distributed worldwide.

X-Celerate Universal Block Pegless Size #3, || Non Sterile;

Product no. 8001-1702; Lot codes: MCYL30A, and MCYL30B.

Orthopedic Devices

1

No

Class II Recall - Worldwide Distribution --- including USA and Canada, United Kingdom.

Xcelerate Patella System Reamer Shaft Assembly; || Non-Sterile; || Howmedica Osteonics Corp., || 325 Corporate Drive; || Mahwah, NJ 07430 || Authorized representative in Europe: || Stryker France ZAC Satolas Green Pusignan || Cedex, France

All lots distributed from lot 69998600 (2/20/1996) to present

Orthopedic Devices

1

No

Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America.

00789504001 VerSys Femoral Head Provisional 40mm -3.5 || 00789504002 VerSys Femoral Head Provisional 40mm +0 || 00789504003 VerSys Femoral Head Provisional 40mm +3.5 || 00789504004 VerSys Femoral Head Provisional 40mm +7 || 00789504005 VerSys Femoral Head Provisional 40mm +10.5 || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty

All lots distributed from lot 69998600 (2/20/1996) to present

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.

00789502601 VerSys Femoral Head Provisional 26mm -3.5 || 00789502602 VerSys Femoral Head Provisional 26mm +0 || 00789502603 VerSys Femoral Head Provisional 26mm +3.5 || 00789502604 VerSys Femoral Head Provisional 26mm +7 || 00789502605 VerSys Femoral Head Provisional 26mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry y and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

All lots distributed from lot 69998600 (2/20/1996) to present

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.

00789502801 VerSys Femoral Head Provisional 28mm -3.5 || 00789502802 VerSys Femoral Head Provisional 28mm +0 || 00789502803 VerSys Femoral Head Provisional 28mm +3.5 || 00789502804 VerSys Femoral Head Provisional 28mm +7 || 00789502805 VerSys Femoral Head Provisional 28mm +10.5 || 12/14 Neck Taper || The provisional heads replicate final femoral implant geometry and are used to trial range of motion, joint stability, and determine appropriate femoral head size and offset during total hip arthroplasty.

Various Polyethylene ImplantsMultiple Item and Lot NumbersARTG Numbers: 98451, 144584, 219196, 219825, 219841, 219858, 223027,223028, 225307, 226020, 227968, 246654, 249554 and 272677

Orthopedic Devices

Model Catalog: 183740 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105925 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105924 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105923 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105914 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105903 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: XL-105833 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 141514 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189080 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189062 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189040 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 189020 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165236 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165232 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model Catalog: 11-165226 (Lot serial: >100 LOT NUMBERS CONTACT MFR); Model

Orthopedic Devices

VANGUARD TOTAL KNEE SYSTEM - DCM - PS PLUS TIBIAL;ARCOMXL RINGLOC LINER;MAXIM KNEE SYSTEM-STEMMED TIBIAL TRAY COMPONENT;TOTAL KNEE SYSTEM - ANTERIOR STABILIZED BEARINGS;RINGLOC BIPOLAR ACETABULAR COMPONENT;MAXIM KNEE SYSTEM-PRIMARY TIBIAL TRAY;HYBRID GLEN

Reference Number 48590100 Lots B40155, B34446, B34447 and B41171.

Orthopedic Devices

1

No

Nationwide Distribution.

Stryker UniVise Spinous Process Fixation Plate System Inserter, Stryker Spine, Non-Sterile. Reference Number 48590100. Manual Surgical Instrument.

All lots manufactured since 1998. Catalog Number 7650-3363. Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430; authorized representative in Europe: Stryker France ZAC Satolas Green Pusignan; Cedex, France.

Orthopedic Devices

1

No

Products were distributed worldwide.

Universal Notch Preparation Guide, Size #3; || Non Sterile; || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430; || authorized representative in Europe: || Stryker France ZAC Satolas Green Pusignan; || Cedex, France.

Orthopedic Devices

Medical electronics / Electromedical devices

Orthopedic Devices

Medical electronics / Electromedical devices

All product with an expiration date between August 2004 and August 2009.

Orthopedic Devices

2

No

Distributed to 492 customers throughout the United States, and 301 customers internationally.

Ultra Power Burs, Sterile, Single-Use.

Lot #145B08

Orthopedic Devices

1

No

Nationwide Distribution -- including states of CO, OR, and TX.

Normed TX 8 Driver, Non-Cannulated (used with the Ascension Total Foot System); Catalog #503004268; distributed by Ascension Orthopedics, Inc., Austin, TX 78754. || Orthopedic manual surgical screwdriver.

Catalog number, Lot Number S-200956, 535U1000 S-200957, 536U1000 S-200958, 537U1000

Orthopedic Devices

1

No

OH, VA

MODIFIED/SPECIAL INSTRUMENT, TURON GLENOID REAMER, REAM AND RUN, Catalog Numbers: || REF S-200956 - 5mm PIN, SIZE 46 || REF S-200957 - 5mm PIN, SIZE 50 || REF S-200958 - 5mm PIN, SIZE 58

Model number 1052; Lots M674180, MAKL170, M674200

Orthopedic Devices

1

No

USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.

Endotrig Trigger Release Sterile Micro Hook Blade || Product Usage: || The blade is intended to release A-1 pulley in endoscopic trigger release procedures.

All serial numbers prior to and including ACA5

Orthopedic Devices

2

No

Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.

smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 || Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation.

Catalog Number: 2111-0000

Orthopedic Devices

1

No

The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.

Trident Insert Impactor

Catalog No.: 6541-2-807 N1A0l, N1K07 N1K14 N1N64 N1W04 N2A11 N2H10 N2L16 N2N04 N2V25 N2V26 N3E08 N3H12 N3H29 N3K02 N3K56 N3L13 N3S33 N3S39 N3T78 N3V21 N3W18 N3W29 N3W47 NYC02 NYC10 NYL09 NZC10 NZH09 NZL08 NZM01 NZS08 NZV09 customer Parts associated with cat. no. 6540-2-807 I-K2072AH00 - Triathlon Tibial Align. Handle with Secondary Lock I-K2336AH00 - Tibial Alignment Handle with Lock I-K2021TA00 - Triathlon Alignment Handle with Navigation Post I-K2059KT00 - Triathlon Tibia Alignment Handle I-K3254TA00 - Triathlon Tibial Alignment Handle with Lock I-K3251AH00 - Triathlon Tibial Alignment Handle for Sizes 1-3 I-K3113TH00 - Triathlon Tibial Alignment Handles (Augment) I-K2980 - Triathlon Tibia Alignment Handle I-K2954AH00 - Triathlon Tibia Alignment Handle I-K2916TA00 - Triathlon Tibial Alignment Handle I-K2797AH00 - Tibial Alignment Handle with no swivel Catalog No. 6541-2-8089 N1K14 N1N63 N1W08 N3K50 N3M43 N3T61 N3V56 N4E36

Orthopedic Devices

1

No

Worldwide Distribution - USA (nationwide) and the countries of Asia Pacific, Canada, Europe, Middle East and Africa (EMEA), and Japan

Tibial Alignment Handle || Triathlon Instruments || CAT #: 6541-2-807 || Nav Tibial Alignment Handle Triathlon Instruments || CAT #; 6541-2-808 || Howmedica Osteonics Corp. || 325 Corporate Drive || Mahwah, NJ 07430 || The tibial alignment handles Cat# 6451-2-807 and 6541-2-808 are part of the Triathlon Knee Instruments set. The alignment handle is used after the tibial resection portion of a total knee arthroplasty procedure. The alignment handle helps holding and orienting the tibial template and trial, which are used to estimate the size and assess the orientation of the final implant. The implant will provide the new bearing surface of the knee, replacing the damaged joint.

Lot numbers 140312147 140613795 140714523

Orthopedic Devices

1

No

US Distribution to Florida, New York and Puerto Rico..

Transforaminal Lumbar Interbody Fusion (TLIF) pack, Catalog # 900-2918 || Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.