CLASS II Device recall · Reported 25 Mar 2015 · FDA Enforcement Report
Thumb Screw for the Synthes Recon Locking Aiming Arm recalled
Synthes is recalling Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX (, distributed nationwide in the US. The recall was initiated on 17 Feb 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1281-2015
- FDA event ID
- 70455
- Recalling firm
- Synthes, West Chester, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Feb 2015
- FDA classified
- 16 Mar 2015
- Reported
- 25 Mar 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Heart & Vascular Devices
Timeline
| 17 Feb 2015 | Recall initiated by company | |
| 16 Mar 2015 | Classified by FDA | +27 days |
| 25 Mar 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Nationwide Distribution
Questions about this recall
Is Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX ( recalled?
Yes. Synthes recalled Thumb Screw for the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX ( on 17 Feb 2015. The recall is Class II and its status is Terminated. Recall number Z-1281-2015.
Why was it 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.
Which lots 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
Where was it sold?
Nationwide Distribution
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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