S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is
FDA device recall Z-2414-2012 · posted 2012-09-20 · Terminated
Recall details
- Recalling firm
- DePuy Orthopaedics, Inc.
- Reason for recall
- Orthopaedics, Inc. (DePuy) is issuing a voluntary recall of four lots of the S-ROM" liner because the Carton label has an Incorrect Color Code Series Designation. We have received one complaint regarding this issue.
- Action taken
- DePuy sent an "URGENT INFORMATION-MEDICAL DEVICE RECALL NOTICE" dated August 22, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Reconciliation Form was included in the letter for customers to complete and return via fax to 574-371-4939. Contact your local Depuy Orthopaedics sales representative for questions related to this recall.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KWZ
- Quantity affected
- 12 liners
- Distribution
- Nationwide Distribution including the states of MA, TX, OH, CA, and NC.
- Date initiated
- 2012-08-22
- Date posted
- 2012-09-20
- Date terminated
- 2013-10-09
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS (K071117) | DePuy Orthopaedics, Inc. | 2007-05-18 |