Synthes 2.7 mm Locking Screws Recalled for Mislabeling as 2.4 mm
Synthes (USA) Products LLC is recalling 98 units of 2.7 mm locking screws that were mislabeled as 2.4 mm. The units were distributed to Tennessee.
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, but the source text identifies the issue as a labeling error without reporting any injuries, illnesses, or deaths. This aligns with the rubric for minor labeling errors or low-risk contamination.
Plain-English summary
Synthes (USA) Products LLC is recalling 98 units of 2.7 mm Locking Screws (Part Number 202.212, Lot Number 3420620) with T8 Stardrive Recess 12mm. These screws are part of the Synthes modular Mini Fragment LCP System, which is intended for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
The recall was initiated because specific lots of the 2.7 mm locking screws were mislabeled as 2.4 mm locking screws. This labeling error could lead to the use of the incorrect screw size during surgical procedures.
The affected units were distributed to the state of Tennessee. Healthcare facilities and providers who have received these specific lots should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- 2.7 mm Locking Screw SLF-TPNG with T8 Stardrive Recess 12mm. The Synthes modular Mini Fragment LCP System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 98
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 (1)
- Part Number 202.212 Lot Number 3420620
Distribution
Distributed in 1 state:
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