Recall Z-0878-2020 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Smith & Nephew, Inc.
LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).
| Date | Dec 16, 2019 |
| Status | Open, Classified |
| Reason | Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications. |
| Root cause | Process change control |
| Action | The firm initiated the recall by letter on December 16, 2019. The letter identified the problem and directed the consignee to remove the affected lots noted in the Urgent Medical Device Recall Notice. |
| Quantity | 59 units |
| Distribution | USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121393 | SMITH & NEPHEW, INC. TOTAL KNEE SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Aug 7, 2012 |