Recall Z-1203-2014 ยท KRO Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
DePuy Orthopaedics, Inc.
REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised dur
| Date | Mar 13, 2014 (initiated Feb 24, 2014) |
| Status | Terminated |
| Reason | DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the |
| Root cause | Packaging |
| Action | DePuy Orthopaedics sent an Urgent Information - Recall Notice dated February 24, 2014, to all affected customers. The notice identified the product, reason for the recall and potential risks associated with using the recalled product. The notice includes response cards for the US Distributors to verify they have read, understood, and are adhering to the directions given in the field communication and for hospitals where consignment inventory is removed a hospital letter is available, as needed. No hospital signatures are required. Distributors are asked to send completed distributor cards to |
| Quantity | 129 |
| Distribution | Worldwide Distribution - USA (nationwide) and Internationally to Canada, Australia, Austria, China, Czech Republic, Denmark, Dubai / UAE, Estonia, France, Germany, Hungary, Iberia, India, Ireland, Israel, Italy, Malaysia, Netherlands, New Zealand, Norway, Pakistan, Poland, Portugal, Russia, Singapor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K896048 | S-ROM/NOILES MARK 3 Joint Medical Products Corp., Mar 14, 1990 |