Reported Oct 31, 2012 · Terminated
SpiraLok 5.0mm with Panacryl without needles Product Number: 222965 SPIRALOK Anchors are primarily used to re-attach…
DePuy Mitek, Inc., a Johnson & Johnson Co.
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 Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Drive · Raynham, MA · 02767-5199
Is this the product you have?
- SpiraLok 5.0mm with
- Panacryl without needles Product Number222965 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow
- Lot codes and dates
- All lot codes
- Amount recalled
- 232 units
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Where it was sold
Why it was recalled
Fracture of SPIRALOK Anchors post op, requiring patient revision
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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