Reported Mar 25, 2015 · Terminated
Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and…
Synthes, 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: Synthes, Inc. · 1302 Wrights Ln E · West Chester, PA · 19380-3417
Is this the product you have?
- Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the Thumb Screw for the Aiming Arm for Titanium Cannulated Tibial Nails-EX (part number 03.010.052). The Recon Locking Aiming Arm for Lateral Entry Femoral Recon Nails- EX is used when locking the Femoral Nail-EX. The Aiming Arm for Titanium (TI) Cannulated Tibial Nails-EX is used when locking the Tibial Nail-EX.
- Lot codes and dates
- Part numbers03.010.048 and 03.010.052
- with Lot Numbers
4874015487402149272624954481496319248740164874022494475049575864963193478401748995644944751495758749720034874018489956549544784957588497200448740194927260495447949575894874020492726149544804963190492253349229754981158492297049230154981159492297149772414981160492297249772424981162492297349811565035905492297449811575035906
- Amount recalled
- 183
Where it was sold
- Nationwide
Why it was recalled
For certain lots, the incorrect raw material of annealed 17-4PH Stainless Steel was used instead of the correct material of heat-treated 304 Stainless Steel. This may lead to stress-corrosion cracking, which can lead to surgical delay or unintended debris entering the surgical site.
This product could cause temporary or reversible health problems — stop using it.
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