Recall record at a glance
| Official record | Z-2396-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Report date | Aug 17, 2016 |
| Recall initiation date | Jul 1, 2016 |
| Quantity | 241 units |
| Location | Mahwah, NJ, United States |
Official product description
Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Why the product was recalled
Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
Distribution information
Worldwide Distribution - US Nationwide
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: E-Mail.
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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