FDA Recall
Terminated
SMR allen wrench 5 mm, product code 9013.50.210
Recall: Z-2707-2016
·
Initiated July 21, 2016
Recall
- Recall Number
- Z-2707-2016
- Event Number
- 74827
- Firm
- Limacorporate S.p.A Via Nazionale 52 San Daniele Del Friuli Italy
- FEI Number
- 3008021110
- Product Code
- LXH
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- July 21, 2016
- Posted
- August 31, 2016
- Terminated
- January 13, 2017
Description
SMR allen wrench 5 mm, product code 9013.50.210
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.
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.
Distribution
US, Italy, Australia
Quantity
76