Synthes Soft Tissue Retractor Recalled for Potential Nut Breakage
Synthes USA HQ, Inc. is recalling 374 Soft Tissue Retractors because the locking screw nut may break if overtightened.
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 is classified as FDA Class II, and the hazard involves a mechanical failure (nut breakage) in a surgical instrument, which poses a risk of harm to patients during procedures, even though no specific injuries are reported in the source text.
Plain-English summary
Synthes USA HQ, Inc. is recalling 374 units of the Synthes Soft Tissue Retractor Small Extendible. The product is distributed in the United States and Canada.
The recall is issued because there is a potential for the locking screw nut to break if the device is overtightened. The retractor is used to facilitate the preparation of the epipereosteal cavity for percutaneous plate insertion.
Affected units include specific part and lot numbers listed in the official recall documentation. Healthcare providers and facilities should check their inventory for these specific units and stop using them if they match the recalled lot numbers.
The recalled product
- Product
- Synthes Soft Tissue Retractor Small Extendible Offset blade facilitates easy preparation of the epipereosteal cavity for percutaneous plate insertion.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 374
Distribution
Distributed nationwide across the United States.
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