rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
FDA device recall Z-2426-2015 · posted 2015-08-20 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
- Action taken
- Branches/Agencies were notified by Stryker of this action by e-mails on June 24, 2015 and an Urgent Medical Device Removal Letter/Acknowledgement Response Form dated June 25, 2015 was sent to the attention of the Risk Manager.
- Root cause
- Packaging change control
- Status
- Terminated
- Product code
- JDB
- Quantity affected
- 16992 total
- Distribution
- Worldwide Distribution.
- Date initiated
- 2015-06-24
- Date posted
- 2015-08-20
- Date terminated
- 2016-04-29
- Location
- Mahwah, NJ
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| RHEAD RADIAL HEAD EXTENDED STEMS (K102180) | Small Bone Innovations, Inc. | 2010-12-20 |