Reported Apr 7, 2021 · Terminated
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components…
DePuy Orthopaedics, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Orthopaedics, Inc. · 700 Orthopaedic Dr · Warsaw, IN · 46582-3994
Is this the product you have?
- ATTUNE¿
- FIXED BEARING KNEE - Product Usagecomposed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design
- Lot codes and dates
- Lot#: 9558300
- Product Code
150670003GTIN 10603295492054 Lot#: 9555958
- Product Code
150670004GTIN 10603295492061 Lot#: 9554006
- Product Code
150670005GTIN 10603295492078 Lot#: 9556397
- Product Code
150670005GTIN 10603295492078 Lot#: 9558618
- Product Code
150670006GTIN 10603295492085 Lot#: 9557992
- Product Code
150670007GTIN 10603295492092 Lot#: 9558238
- Product Code
150670008GTIN 10603295492108 Lot#: 9558239
- Product Code
150670008GTIN 10603295492108 Lot#: 9555613
- Product Code
150670009GTIN 10603295492115
- Amount recalled
- 102 units total (Domestic: 6 units, Foreign: 86 units)
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
This product could cause temporary or reversible health problems — stop using it.
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