Recall Z-1103-2021 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DePuy Orthopaedics, Inc.
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
| Date | Jan 8, 2021 |
| Status | Terminated |
| Reason | The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots. |
| Root cause | Nonconforming Material/Component |
| Action | On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices. |
| Quantity | 60 sleeves |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K063633 | DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVES DePuy Orthopaedics, Inc., Mar 2, 2007 |