Proven Porous CR Femur. Implantable orthopedic device
FDA device recall Z-0496-05 · posted 2005-02-03 · Terminated
Recall details
- Recalling firm
- Stelkast Co
- Reason for recall
- Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
- Action taken
- The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 105 units
- Distribution
- The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
- Date initiated
- 2004-09-24
- Date posted
- 2005-02-03
- Date terminated
- 2005-02-07
- Location
- Mcmurray, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STELKAST PROVEN KNEE SYSTEM (K002281) | Stelkast Company | 2000-08-17 |