SMR allen wrench 5 mm, product code 9013.50.210
FDA device recall Z-2707-2016 · posted 2016-08-31 · Terminated
Recall details
- Recalling firm
- Limacorporate S.p.A
- Reason for recall
- 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 taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 76
- Distribution
- US, Italy, Australia
- Date initiated
- 2016-07-21
- Date posted
- 2016-08-31
- Date terminated
- 2017-01-13
- Location
- San Daniele Del Friuli, Italy
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