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Synthes, Inc. recalls Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (part number 03.010.048) and the
Recalled March 25, 2015 · FDA recall Z-1281-2015 · Synthes
Hazard
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. · FDA Class II
Units
183
Sold at
Nationwide Distribution
Description
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.
Product
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.
Manufacturer(s)
Synthes, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →