Vanguard Knee Instrumentation Tibial Resection Tower Universal with alignment tower geometry, REF 32487557, LOT 2561334,

FDA device recall Z-1223-2012 · posted 2012-03-19 · Terminated

Recall details

Recalling firm

Biomet U.K., Ltd.

Reason for recall

This recall was initiated following a report that a bag labeled as REF. 32-487557/Lot no 2561334 (Vanguard Tibial Resection head universal w/ alignment tower) actually contained a Ref. 32-487002/Lot no. 2561329 (Vanguard Distal cutting Block w/out handle attachment). Investigation found packaging of the affected product may contain the incorrect item.

Action taken

Biomet U.K. sent a Field Safety Corrective Action notice dated February 14, 2012 to all affected customers. The notice identified the affected products, problem and actions to be taken. Customers were instructed to locate, discontinue use and quarantine the recalled products pending return to Biomet. The letter recommended customers provide the notice to any other organization who may have received the affected instruments. Customers were instructed to complete and return without delay the attached "Fax-Back Response Form" acknowledging receipt of notice and indicating the quantity of products to be returned. For questions call +44 (0) 1656 761658, fax: +44 (0) 1656 645454 and e-mail uk.complaints@biomet.com

Root cause

Packaging change control

Status

Terminated

Product code

LXH

Quantity affected

4 units

Distribution

Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA

Date initiated

2012-02-14

Date posted

2012-03-19

Date terminated

2012-11-06

Location

South Wales, Bridgend, United Kingdom