ReUnion Fracture Stem Humeral Component - PureFix HA; Shoulder prosthesis. Distal Diameter - 7 to 15mm; Hydroxylapatite
FDA device recall Z-0080-2008 · posted 2007-11-01 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- The plasma spray may delaminate from the proximal portion of the humeral stem.
- Action taken
- Market Withdrawal letters were sent on May 9, 2007 via Federal Express. Letters to implanting physicians will be mail on or about mailed November 1, 2007. Stryker is also reissuing original letters indicating that this action is a Recall and advising of possible health hazards.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 232 units
- Distribution
- One hospital in Akron OH and 12 Stryker branches/agencies
- Date initiated
- 2007-05-09
- Date posted
- 2007-11-01
- Date terminated
- 2008-03-07
- Location
- Mahwah, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOLAR REUNION FRACTURE STEM (K062113) | Howmedica Osteonics Corp. | 2006-10-03 |