Recall record at a glance
| Official record | Z-0323-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Synthes (USA) Products LLC |
| Report date | Dec 2, 2015 |
| Recall initiation date | Nov 2, 2015 |
| Quantity | 229 |
| Location | West Chester, PA, United States |
Official product description
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.
Why the product was recalled
It was discovered that the above part number and lot of 2.4mm Locking Screws may contain the incorrect package insert (GP2613, VA-LCP Distal Radius System). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP System).
Distribution information
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, and the country of Canada.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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