Howmedica Restoration ADM Trial Cup Holder; Non Sterile; Benoist Girard, Cedex, France; Distributed by Howmedica Osteoni

FDA device recall Z-1201-2010 · posted 2010-04-19 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

The Restoration ADM Trial Cup Holder may not have been assembled correctly.

Action taken

An "URGENT PRODUCTION OPERATION" letter dated January 21, 2010, was sent to customers via FedEx. The letter described the product, problem and actions to be taken by customer. The customers should follow the instructions on the enclosed PRODUCT BULLETIN. The customer should check their internal inventory immediately and quarantine all affected devices, identify if the device is correctly assembled and complete the Product Correction Acknowledgement Form and fax it to (201) 831-6069. If you have any questions, feel free to contact Rich Wolyn, Manager, Divisional Regulatory Reporting at (201) 831-5158.

Root cause

Other

Status

Terminated

Product code

MEH

Quantity affected

5 units

Distribution

Nationwide distribution: AZ, CA and OR

Date initiated

2010-01-21

Date posted

2010-04-19

Date terminated

2012-06-20

Location

Mahwah, NJ