Recall record at a glance
| Official record | Z-1523-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Gmbh |
| Report date | May 6, 2015 |
| Recall initiation date | Mar 18, 2015 |
| Quantity | 30 units |
| Location | Winterthur, Switzerland |
Official product description
Anatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Why the product was recalled
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Distribution information
Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
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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