Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700...
FDA Recall #Z-1132-2016 — Class II — January 11, 2016
Product Description
Product 34 consists of all product under product code: JWH and same usage: Item no: 522001700 I/B II KNEE DOMED PATELLA 522001800 I/B II KNEE DOMED PATELLA 522001900 I/B II KNEE DOMED PATELLA 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
512
Distribution
US Nationwide Distribution
Code Information
lot no.: 61932449 62126613 62204611 62213348 62406239 62203954 62204587 62332733 62236654 62406245
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated