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.

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 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

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 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;

Model: Part Number 3256-01, Affected: All

Orthopedic Devices

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.

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

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.

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.

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.