Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY C...
FDA Recall #Z-1150-2016 — Class II — January 11, 2016
Product Description
Product 52 consists of product code: HWC and same usage: Item no: 525004530 NEXGEN OSTEOTOMY CORT BON 525004540 NEXGEN OSTEOTOMY CORT BON 525006545 NEXGEN OSTEOTOMY CORT BON 525006560 NEXGEN OSTEOTOMY CORT BON 525006565 NEXGEN OSTEOTOMY CORT BON for use in total knee arthroplasty
Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Recalling Firm
Zimmer Manufacturing B.V. — Mercedita, PR
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
925
Distribution
US Nationwide Distribution
Code Information
lot no.: 61996176 61996176N 61996177 61996177N 61687334 61926537 62308501 61811187 61996179 61996179N
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated