Product 35 consists of all product under product code: JWH and same usage: Item no: 52200730...
FDA Recall #Z-1133-2016 — Class II — January 11, 2016
Product Description
Product 35 consists of all product under product code: JWH and same usage: Item no: 522007300 I/B II KNEE FLUTED ROD, 1 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
49
Distribution
US Nationwide Distribution
Code Information
lot no.: 62207450
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated