Reported Nov 28, 2012 · Terminated
Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA…
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 Drive · Mahwah, NJ · 07430
Is this the product you have?
- Stryker Orthopaedics Torx 6.5mm Cancellous Bone Screw Ref 2030-6535-1 The 6.5mm Cancellous Bone Screws are used in THA when the surgeon elects to use a cluster/multi-hole shell in the acetabulum. The screws are intended to provide initial cup fixation and help prevent spin-out of the cup due to physical loading from the patient. They are intended as supplemental fixation.
- Lot codes and dates
- Catalog No2030-6535-1
- Lot Code
MLDNAVMLDXV2MLH11MMLH17RMLH3K8MLH4L6MLH7RVMLHK1XMLHL99MLJDJT Ref 2030-6535-1
- Amount recalled
- Approximately 358 units
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stryker has received reports from the field indicating that certain lots of 6.5mm Cancellous Bone Screws are either associated with a product mix or potentially associated with a product mix. Packaging associated with a 35 mm screw may contain a 25mm screw. Conversely, packaging associated with a 25mm screw may contain a 35mm screw.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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