Recall Z-2414-2012 ยท KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
DePuy Orthopaedics, Inc.
S-Rom Total Hip System Poly Liner Packaging: The insert is placed into an inner foil pouch and vacuum sealed; a ring is placed into a Tyvek/PET pouch and sealed; the foil pouch and Tyvek/PET pouch are placed into a nylon outer pouch and sealed. This is then placed into a folding carton, labeled, and shrink-wrapped. Description: Total Hip System Poly Dial Liner is part of the S-ROM Total Hip S
| Date | Sep 20, 2012 (initiated Aug 22, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Labeling Change Control |
| Action | 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. |
| Quantity | 12 liners |
| Distribution | Nationwide Distribution including the states of MA, TX, OH, CA, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071117 | MODIFICATION TO PINNACLE CONSTRAINED ACETABULAR LINERS DePuy Orthopaedics, Inc., May 18, 2007 |