Recall record at a glance
| Official record | Z-0941-2013 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Synthes USA HQ, Inc. |
| Report date | Mar 20, 2013 |
| Recall initiation date | Jan 11, 2013 |
| Quantity | 136 |
| Location | West Chester, PA, United States |
Official product description
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.
Why the product was recalled
The L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
Distribution information
USA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
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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