Recall Z-1219-2018 ยท HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
DePuy Orthopaedics, Inc.
(1) Sigma HP Cemented Trochlea Size 1 Narrow Left, Catalog Number: 102403100, GTIN: 10603295001614; (2) Sigma HP Cemented Trochlea Size 2 Narrow Left, Catalog Number: 102403200, GTIN: 10603295001621; (3) Sigma HP Cemented Trochlea Size 3 Narrow Left, Catalog Number: 102403300, GTIN: 10603295001638; (4) Sigma HP Cemented Trochlea Size 4 Narrow Left, Catalog Number: 102403400, GTIN: 10603295001645;
| Date | Mar 20, 2018 (initiated Dec 21, 2017) |
| Status | Terminated |
| Reason | The SIGMA HP PFJ Cemented Trochlear Implants, a standalone component of the partial knee system is being recalled based on elevated revision rates observed as part of the company s post market surveillance process. |
| Root cause | Under Investigation by firm |
| Action | Notifications were sent to the firm's consignees with the following instructions. Immediately Inspect Inventory: DISTRIBUTORS & SALES OFFICES: Inspect all inventory to identify any affected devices. 2. Return Affected U.S. Distributor/Sales Office Inventory: If any affected devices are found in a U.S. Distributors/Sales Offices inventory, return to: DePuy Synthes Joint Reconstruction 3. To Expedite the Return Process: Be sure to reference H17-19 on all return paperwork and/or online return forms and on the outside of the box when returning recalled devices. 4. Upon receipt of the affected devi |
| Quantity | 2110 |
| Distribution | Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K061648 | DEPUY GRADUATED COMPARTMENTAL KNEE (GCK) DePuy Orthopaedics, Inc., Sep 11, 2006 |