Z-2707-2016Class II

SMR allen wrench 5 mm, product code 9013.50.210

Name: Z-2707-2016 SMR allen wrench 5 mm, product code 9013.50.210
Creator: Limacorporate S.p.A
Published: 2016-07-21
License: https://open.fda.gov/license/

Limacorporate S.p.A. / initiated 2016-07-21 / Terminated / root cause: manufacturing process

FDA source

Limacorporate S.p.A began a recall of SMR allen wrench 5 mm, product code 9013.50.210 on 2016-07-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2707-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-21
Posted: 2016-08-31
Terminated: 2017-01-13
Recalling firm: Limacorporate S.p.A.
Product: SMR allen wrench 5 mm, product code 9013.50.210
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: manufacturing process
FDA 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 in commerce: 76
Distribution: US, Italy, Australia
Product codes and lots: 14AA311

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2707-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2707-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-07	2016-08-31

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)