Recall Z-0730-2019 ยท LXH Orthopedic Manual Surgical Instrument
Smith & Nephew, Inc.
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
| Date | Jan 7, 2019 |
| Status | Terminated |
| Reason | The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble. |
| Root cause | Process control |
| Action | The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product. |
| Quantity | 72 units |
| Distribution | NY, TN, Germany, Italy, Great Britain, Singapore |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123598 | SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATION Smith & Nephew, Inc., Jun 28, 2013 |