Reported Nov 7, 2012 · Terminated
"***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908…
Linvatec Corp. dba ConMed Linvatec
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: Linvatec Corp. dba ConMed Linvatec · 11311 Concept Blvd · Largo, FL · 33773-4908
Is this the product you have?
- "***All in one CrossFT***Punch***PFT-00M***4.5mm to 6.5mm***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***" To create pathway for insertion of CrossFT Suture Anchor into bone.
- Lot codes and dates
- Lot # 330889
- and CatalogPFT-00M - No Expiration date
- Amount recalled
- 2 units
Where it was sold
- Nationwide
- MN
Why it was recalled
ConMed Linvatec is recalling the product due to the punch being mis-assembled with the incorrect handled. The correct handle is a clear anodized silver colored handle.
This product could cause temporary or reversible health problems — stop using it.
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