VERSYS 7.5 INCH BEADED FC prosthesis recall
VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip…
Why was VERSYS 7.5 INCH BEADED FC prosthesis recalled?
LDPE bag containing the implant adheres to the highly polished implant surface.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Item numbers: 00-7843-012-18 00-7843-013-18 00-7843-015-18 00-7843-015-24 00-7843-016-18 00-7843-016-24 00-7843-018-18 00-7843-018-24 00-7843-019-18 00-7843-019-24 00-7843-021-18 00-7843-021-24 00-7843-022-18 00-7843-022-24 Lot numbers: 11006277 61775244 61781982 61786860 61815081 61879442 61937678 61956718 61956722 61981808 61993659 62029064 62043111 62143772 77000810 77000822
- Product
- VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 101
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
- Recall date
- March 2, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)