Vanguard Knee Instrumentation Distal Cutting Block without Handles, REF 32-487002 LOT 2561329, Biomet UK Ltd, South Wales, UK Used to guide a saw blade in resecting the the distal femor. Intended to be used with a femoral alignment guide guide.
FDA Recall Z-1222-2012 · Posted 2012-03-19
Recalling FirmBiomet U.K., Ltd.
Recall StatusTerminated
Product CodeLXH
Date Initiated2012-02-14
Date Terminated2012-11-06
Product Quantity4 units
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.
Firm Action
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 [email protected]
Root Cause
Packaging change control
Distribution Pattern
Worldwide Distribution - in the countries of France, Japan, Italy, Netherlands, UK , no devices distributed in the USA
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.