Z-0829-2011

Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument...

Name: Z-0829-2011 Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument...
Creator: Biomet, Inc.
Published: 2010-09-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2010-09-10 / Terminated

FDA source

Biomet, Inc. began a recall of Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for... on 2010-09-10. The reason FDA records is "The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0829-2011
Status: Terminated
Initiated: 2010-09-10
Posted: 2010-12-28
Terminated: 2011-01-19
Recalling firm: Zimmer GmbH
Product: Vanguard Knee Instruments offset reamer bushing - angled, REF 32-488519, Biomet Bridgend, UK. This instrument is used to prepare the tibial cancellous bone for the tibial offset tray.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The firm has initiated the action following a report that during surgery the Offset Reamer Brushign would not mate with the prepartion mask. After a 5 minute delay in surgery the procedure was completed using another attachment that was on hand. There was no injury to the patient.
FDA root cause: Other
Action: The firm, BIOMET, sent a "FIELD SAFETY NOTICES" dated September 10, 2010, addressed to the head of orthopaedic departments, trauma departments, operating departments, sterile service departments, procurement, supplies and risk management. The notice described the product, problem and action to be taken by the customers. The letters instructed the customers to locate and immediately quarantine the recalled device; to complete and return the attached "FAX BACK RESPONSE FORM" via fax to +44 (0) 1656 645454, and the recalled device for credit via mail to Biomet UK Ltd, Waterton Industrial Estate, Bridgend, CF31 3XA. The customers were also instructed to inform all in their organization who are using or ordering the products and send a copy to the organization to which potentially affected products may have been transferred. If you have any questions regarding this communication, please contact the Quality Manager at +44 (0) 1656 655221 or email: [email protected].
Quantity in commerce: 16 units
Distribution: International distribution only: Netherlands, Germany, France, Spain, Italy and Denmark
Product codes and lots: 1723336, 1768306, 2049011, ZB090424.

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)