Synthes 2.4mm Locking Screws Recalled for Incorrect Package Insert
Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws because they may contain the wrong package insert.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation error (incorrect package insert) with no reported injuries or illnesses, fitting the criteria for a Low severity recall involving packaging or documentation issues.
Plain-English summary
Synthes (USA) Products LLC is recalling 229 units of 2.4mm Locking Screws (Part Number 212.818, Lot Number 7856527). The recall was initiated because it was discovered that these specific screws may contain an incorrect package insert (GP2613, VA-LCP Distal Radius System) instead of the correct one (GP2615, Modular Mini Fragment LCP System).
The affected products were distributed in the states of IA, OH, CO, FL, TX, MA, NY, OR, SC, VA, WV, TN, MO, PA, CT, GA, WA, CA, AL, IN, MI, NJ, VT, ID, KS, MN, and MD, as well as in Canada. The screws are intended for the fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
Healthcare providers and facilities that have received these products should stop using them and contact Synthes (USA) Products LLC for further instructions regarding the return or replacement of the affected units.
The recalled product
- Product
- 2.4MM locking screw SLF-TPNG with Stardrive Recess 18 mm. Intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bones and small bone fragments, particularly in osteopenic bone.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 229
Distribution
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