Reported Sep 21, 2016 · Terminated
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio…
Stryker Howmedica Osteonics Corp.
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: Stryker Howmedica Osteonics Corp. · 325 Corporate Dr · Mahwah, NJ · 07430-2006
Is this the product you have?
- Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement polymerization occurs.
- Lot codes and dates
199 of 199 codes
Catalog No. 3182-1000 Lot #'s: RD8E100RD8A054TTRD8A054TRD8E099MRD8E099ARD8E099RD8A054ARD8E099DRD8A053ARD8A054RD8A053TRD7K062LRD8A052ARD8A052ERD8A052RD8A053RD7E128DRD5T290HRD7E128TRD5S262DRD5T290WRD7K062ERD5S262XRD7E128YRD7A076MARD6W102MARD7K062ARD7K062RD7E128HRD7A076ARD7E128ARS7E128RD6W103DRD6V108JRD6V108KRD6V108HRD7A076HRD6V112MRD7A074DRD7A076JRD6V112HRD6W102mRD5H286ARD2V022RD2K049RD6W103RD5H286JRD2T037ARD7A076MRD6S136ARD5H286RD2V031CRD5N361TRD6V112ARD4M068JRD2V021CRD7A076RD6V112RD4E226WRD2V021
- Amount recalled
- 2,039 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
- Nationwide
Why it was recalled
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
This product could cause temporary or reversible health problems — stop using it.
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