Product 28 consists of all product under product code: JDI and same usage: Item no: 3290260500...
FDA Recall #Z-1126-2016 — Class II — January 11, 2016
Product Description
Product 28 consists of all product under product code: JDI and same usage: Item no: 32902605000 FEMORAL HD 28MM MEDIUM 32902604000 FEMORAL HD 28MM SHORT 32902604035 FEMORAL HD 28MM SHT+ 3.5M For use in total or hemi hip 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
Distribution
US Nationwide Distribution
Code Information
lot no.: 62185968 62273370 62339644 62162469 62279774 62279774N 62221051 62279775 62279775N
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated