Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter fem
FDA device recall Z-2396-2016 · posted 2016-08-11 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
- Action taken
- Stryker notified Branches/Agencies of the Urgent Medical Device Recall by e-mail on July 1, 2016 and an "Urgent Medical Device Recall Letter and Business Reply Form" was sent to branches, agents and hospital risk management via UPS (with return receipt) on July 5, 2016. The letter identified then affected product, problem and actions to be taken. For questions call (201) 831-6693.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 241 units
- Distribution
- Worldwide Distribution - US Nationwide
- Date initiated
- 2016-07-01
- Date posted
- 2016-08-11
- Date terminated
- 2017-06-08
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXETER HIP STEM (K110290) | Howmedica Osteonics Corp. | 2011-09-27 |