Recall Z-2707-2016 ยท LXH Orthopedic Manual Surgical Instrument
Limacorporate S.p.A
SMR allen wrench 5 mm, product code 9013.50.210
| Date | Aug 31, 2016 (initiated Jul 21, 2016) |
| Status | Terminated |
| Reason | Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles. |
| Root cause | Nonconforming Material/Component |
| Action | The firm received two complaints from the US field about the inta-operative malfunction with the SMR allen wrench 5mm (product code 9013.50.210) with the T-handle. Both parts involved were manufactured with the same lot #14AA311. No adverse effects for patients reported. |
| Quantity | 76 |
| Distribution | US, Italy, Australia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.