Synthes Recalls Three Titanium Tibial Nail End Caps for Missing Inspection
Synthes is recalling three units of a titanium end cap for tibial nails because they were shipped before a required internal inspection was completed.
What this means for you
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, and the source text indicates a procedural failure (shipping before inspection) without reporting specific injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes, Inc. is recalling three units of the Titanium End Cap with T40 StarDrive Recess, 0mm Extension for Titanium Tibial Nails-EX. The product is part of the Synthes Tibial Nail System EX, which is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft.
The recall was initiated because the specific part and lot number were packaged and shipped prior to the completion of a required internal inspection. The affected units are identified by Part # 04.004.000 and Lot # 7950994.
The affected units were distributed in the United States to the states of Missouri and South Carolina. Consumers and healthcare providers should check their inventory for this specific part and lot number and stop using the product if found.
The recalled product
- Product
- TITANIUM END CAP WITH T40 STARDRIVE RECESS, 0MM EXTENSION FOR TITANIUM TIBIAL NAILS-EX; Synthes Tibial Nail System EX is intended to stabilize fractures of the proximal and distal tibia and the tibial shaft; open and closed tibial shaft fractures; certain pre-and post-isthmic fra
- Manufacturer
- Synthes, Inc.
- Hazard
- Affected units
- 3
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 (2)
- Part # 04.004.000
- lot # 7950994
Distribution
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