Recall record at a glance
| Official record | Z-0119-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Gmbh |
| Report date | Oct 21, 2015 |
| Recall initiation date | Sep 3, 2015 |
| Quantity | 57,603 units |
| Location | Winterthur, N/A, Switzerland |
Official product description
Zimmer Natural Nail CM Long. Intramedullary Fixation Rod. The Zimmer Natural Nail System is intended for temporary fracture fixation and stabilization of the bone.
Why the product was recalled
In about 5% of tested samples, the outer tray was found to be compromised. Risks: A damaged outer tray detected during surgery may cause a delay in surgery to obtain another implant. If a compromised packaging is not detected prior or during a surgery by the user, it may lead to periprosthetic infection. This may result in revision or multi-stage revision to treat the infection.
Distribution information
US Nationwide distribution.
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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