Z-0705-2008

Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc...

Name: Z-0705-2008 Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc...
Creator: Biomet, Inc.
Published: 2007-10-18
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2007-10-18 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN on 2007-10-18. The reason FDA records is "The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component". 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-0705-2008
Status: Terminated
Initiated: 2007-10-18
Posted: 2008-02-05
Terminated: 2008-03-11
Recalling firm: Zimmer GmbH
Product: Biomet RINGLOC + Instrumentation Impactor Plate, Size 28; REF/Part#: 31-400628, Biomet Orthopedics, Inc., Warsaw, IN.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The instrument will not lock onto the impactor handle; the device was distributed without assembly of the Bal Seal component.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Distributors were notified of the device defect by letter (Urgent Field Correction Notice) dated 10/18/07, and provided with assembly instructions and parts, and instructed to make corrections at consignee locations.
Quantity in commerce: 141 total for all recalls Z-0700-0705-2008
Distribution: Worldwide-USA, Germany, The Netherlands, Sweden and The United Kingdom.
Product codes and lots: Lot Number: 038730.

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)