Thumb Screw for the Synthes Recon Locking Aiming Arm recall
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…
Why was Thumb Screw for the Synthes Recon Locking Aiming Arm 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part numbers:03.010.048 and 03.010.052 with Lot Numbers: 4874015 4874021 4927262 4954481 4963192 4874016 4874022 4944750 4957586 4963193 4784017 4899564 4944751 4957587 4972003 4874018 4899565 4954478 4957588 4972004 4874019 4927260 4954479 4957589 4874020 4927261 4954480 4963190 4922533 4922975 4981158 4922970 4923015 4981159 4922971 4977241 4981160 4922972 4977242 4981162 4922973 4981156 5035905 4922974 4981157 5035906
- 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…
- Recalling firm
- Synthes, Inc.
- Quantity
- 183
- Distribution
- Nationwide Distribution
- Recall date
- March 25, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)