Z-2505-2010

Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605

Name: Z-2505-2010 Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
Creator: Biomet, Inc.
Published: 2010-07-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-07-28 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605 on 2010-07-28. The reason FDA records is "There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" The recalling frim conducted tests to determine the effects of theis change...". 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-2505-2010
Status: Terminated
Initiated: 2010-07-28
Posted: 2010-09-25
Terminated: 2012-10-01
Recalling firm: Zimmer GmbH
Product: Modular Microplasty Cup impactor 1/4" - 28 thread insert , REF 31-400605
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: There was a clerical error in order entry which resulted in the recalling firm recieving spring components from a supplier made of "music wire" The recalling frim conducted tests to determine the effects of theis change in materials. The testing showed that the wire would oxidize and there would be early failure of the device.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: The firm send URGENT MEDICAL DEVICE RECALL NOTICES to its distributors on 7/28/2010. The notices instructed the distributors to discontinue use of the product and return it to Biomet.
Quantity in commerce: 331 total for both products
Distribution: US, Australia, Canada, Mexico, Chile, Japan.
Product codes and lots: 106623, 106624, 106625, 106626, 106627, 106628 110405 and 110423.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)