Synthes Large Combination Clamp Recalled Due to Oversized Hex Nuts
Synthes USA is recalling 136 Large Combination Clamps because oversized hex nuts prevent standard 11 mm sockets and wrenches from fitting.
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 describes a functional defect (oversized nuts) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity score.
Plain-English summary
Synthes USA HQ, Inc. is recalling 136 units of the Large Combination Clamp/Large External Fixation System, Part Number 390.005. The recall involves specific lot numbers: 6602070, 6582333, 6581191, and 6581193.
The recall was initiated because the L1 hex nuts used to tighten the Large Combination Clamp were oversized. As a result, standard 11 mm sockets and wrenches will not fit on the hex nuts, which may prevent the device from being properly tightened during use.
The affected products were distributed nationwide in the United States, including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA. The Large External Fixation system is intended for the treatment of long bone and pelvic fractures that require external fixation. Healthcare providers and facilities should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Large Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
- Manufacturer
- Synthes USA HQ, Inc.
- Hazard
- Affected units
- 136
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 (4)
- Lot Numbers 6602070
- 6582333
- 6581191
- and 6581193
Distribution
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