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Crédits
Devices
Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
Modèle / numéro de série
Part number: 49-1100, Lot Number 17301-L125.
Classification du dispositif
Orthopedic Devices
Classe de dispositif
2
Dispositif implanté ?
Yes
Distribution
United States (IA, NV, CO, AZ, NY, MD, IL, VA, MN, MI, NC, CT, LA, AR, GA, CA, MO, WA, OK and AL).
Description du dispositif
Orthofix Spinal Implants; Pillar SA PEEK Spacer System Instrument Case. || Case contents: Implant Insertion Instrument, Straight Tamp, Bone Awl Drill Guide, Straight Drill, U-Joint Driver with and without retention, Flex Shaft Driver, Trial Insertion Instrument, Drill Tips, Cover Plate Inserter, Cover Plate Driver, Cover Plate Holder, Ratcheting Handle, Torque Limiting Handle, Hex Driver, Distractors/Sizers, Sizers REF: 49-0021: Orthoflex Spinal Implants, 1211 Hamburg Tnpk, Suite 300, Wayne, NJ 07470. || The Pillar SA Implant Insertion Instrument is intended for intraoperative use in placing/inserting Pillar SA implants into a prepared interbody space.
Manufacturer
Orthofix, Inc
1 Event
Rappel de Device Recall BLACKSTONE PILLAR SA PARTIAL VERTEBRAL BODY REPLACEMENT DEVICE
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Fabricant
Orthofix, Inc
Adresse du fabricant
Orthofix, Inc, 1720 Bray Central Dr, McKinney TX 75069-8207
Société-mère du fabricant (2017)
Orthofix International Nv
Source
USFDA
Language
English
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