Synthes Screw Inserter Recalled for Incorrect Etched Graphics
Synthes (USA) Products LLC is recalling 793 units of the Screw Inserter because the etched graphics may not correspond to the instrument's actual angle.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The defect is a labeling error (incorrect etched graphics) rather than a structural failure or contamination, and no injuries are reported in the source text.
Plain-English summary
Synthes (USA) Products LLC is recalling 793 units of the Synthes Screw Inserter, an orthopedic device used with Intramedullary Rods. The device is used to secure the head element to the head element inserter to prevent disengagement during insertion.
The recall is due to a labeling defect where certain lots of the Screw Inserter may be etched with incorrect graphics. Specifically, the orientation of the etched image of the oblique angle on the Screw Inserter may not correspond to the tip of the angle of the instrument.
The affected products are distributed nationwide in the United States. The recall involves Part Number 03.037.025 and specific lot numbers including 8911887, 8911975, 9166356, 9285766, 9286671, 9319408, 9375245, 9375251, 9388359, 9388360, 9393071, 9393074, 9393075, 9393076, 9409795, 9409796, 9422892, 9422895, 9498455, 9310899, 9310900, and 9319407. Healthcare providers should check their inventory for these specific part and lot numbers.
The recalled product
- Product
- Synthes Screw Inserter; for use with Intramedullary Rod, orthopedic device. Used to secure the head element to the head element inserter to prevent disengagement during head element insertion.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 793
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Part Number 03.037.025 Lot Numbers 8911887
- 8911975
- 9166356
- 9285766
- 9286671
- 9319408
- 9375245
- 9375251
- 9388359
- 9388360
- 9393071
- 9393074
- 9393075
- 9393076
- 9409795
- 9409796
- 9422892
- 9422895
- 9498455
- 9310899
Distribution
Distributed nationwide across the United States.
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