Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diamete...

FDA Recall #Z-1676-2016 — Class II — May 4, 2016

Recall #Z-1676-2016 Date: May 4, 2016 Classification: Class II Status: Terminated

Product Description

Periarticular plating system, cancellous bone screw, partially threaded, hex head, 4.0 mm diameter, 16 mm length 47234702116

Reason for Recall

A small hole may be present in the inner tray of specific lots of sterile Hip and Trauma Implant Screws.

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

99

Distribution

Worldwide distribution. US nationwide, Korea, Japan, Argentina, Brazil, Singapore, Taiwan, China, El Salvador, Australia, India, Hong Kong, Chile, Germany, Italy, France, Spain, UK, Sweden, Canada.

Code Information

LOT: 63146423

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated