Synthes Soft Tissue Retractor Recalled for Locking Nut Malfunction
Synthes USA HQ, Inc. is recalling 374 units of the Small Extendible Soft Tissue Retractor due to a locking nut malfunction.
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, and the source text does not report any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 374 units of the Synthes Soft Tissue Retractor Small Extendible. The product is identified by Part J5957AC (old) and Part J5957F (new). The device is designed to facilitate the preparation of the epipereosteal cavity for percutaneous plate insertion.
The recall was initiated because the locking nut, also referred to as the clamping sleeve, may malfunction. This defect could affect the device's ability to maintain its position during use.
The affected units were distributed nationwide in the United States and internationally to Canada and Mexico. Healthcare professionals and facilities that have received these devices should stop using them and contact Synthes USA HQ, Inc. for instructions on return or replacement.
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
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 J5957AC (old)
- and Part J5957F (new)
Distribution
Distributed nationwide across the United States.
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