Synthes Thumb Screws Recalled Due to Incorrect Stainless Steel Material
Synthes, Inc. is recalling 183 thumb screws for orthopedic aiming arms because incorrect raw material was used, which may lead to stress-corrosion cracking.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device where a material defect may lead to stress-corrosion cracking and unintended debris entering the surgical site. Per the rubric, this is classified as High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Synthes, Inc. is recalling 183 units of thumb screws used with the Synthes Recon Locking Aiming Arm for Lateral Entry Femoral Nails-EX and the Aiming Arm for Titanium Cannulated Tibial Nails-EX. The affected parts are identified by specific part numbers (03.010.048 and 03.010.052) and a list of lot numbers provided in the recall documentation. The products were distributed nationwide.
The recall was initiated because the incorrect raw material, annealed 17-4PH Stainless Steel, was used instead of the correct heat-treated 304 Stainless Steel for certain lots. This material error may lead to stress-corrosion cracking in the device components.
If the thumb screws crack, it can lead to surgical delay or unintended debris entering the surgical site. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- Synthes, Inc.
- Affected units
- 183
Distribution
Distributed nationwide across the United States.
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