FDA Medical Device Recalls (openFDA)
Limacorporate S.p.A: SMR allen wrench 5 mm, product code 9013.50.210
- Recall number
- Z-2707-2016
- Recalling firm
- Limacorporate S.p.A
- Product
- SMR allen wrench 5 mm, product code 9013.50.210
- Status
- Terminated
- Initiated
- 2016-07-21
- Posted
- 2016-08-31
- Terminated
- 2017-01-13
- 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
- Lot, serial or model codes
- 14AA311
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3008021110
- Firm city
- San Daniele Del Friuli
- Firm state
- not on file
- Firm country
- Italy
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28