Solar HA Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307 to 5351-4317. For use as a Shou
FDA device recall Z-1236-2008 · posted 2008-06-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Delamination: Loosening of the titanium plasma coating on the product was observed on twelve non-distributed units.
- Action taken
- On 11/28/2007, Stryker Orthopaedics sent, via FedEx, Urgent Product Recall notification letters to distributors, hospitals, surgeons and hospitals' Chiefs of Orthopaedics informing them of the firm's voluntary recall of the affected product. They were instructed to discontinue use of the product and to have the units returned to the firm. Distributors were further instructed to notify their customers using the sub-recall letter provided by the firm. The letter to surgeons also informed them to monitor their patients who had received an implant of the product.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 915 units
- Distribution
- Nationwide - USA
- Date initiated
- 2007-11-15
- Date posted
- 2008-06-26
- Date terminated
- 2010-01-25
- 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 PUREFIX HA SHOULDER (K061677) | Howmedica Osteonics Corp. | 2006-07-10 |