Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw

FDA device recall Z-0818-2011 · posted 2010-12-27 · Terminated

Recall details

Recalling firm

DePuy Spine, Inc.

Reason for recall

The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy

Action taken

Depuy Spine issued an "URGENT-VOLUNTARY PRODUCT RECALL NOTIFICATION" via e-mail on October 2, 2010 to customers. The notification describes the product, problem and action to be taken by customers. The customers were instructed to please distribute this information to appropriate personnel at their facility and return any caddies that they may have to their local distributor for DePuy Spine products. Depuy will return devices to customer promptly (within two business days), after reworking the devices by removing the scale altogether. Once the product is fully corrected, Depuy will provide the customers with a new and updated unit with the corrected scale markings. If you should have any questions or concerns regarding this action, please contact DePuy Spine Customers Service at 800-227-6633.

Root cause

Labeling design

Status

Terminated

Product code

LRP

Quantity affected

121 units

Distribution

Nationwide distribution: USA including states of: AR, AZ, CA, FL, HI, IA, IL, KY, LA, MA, MI, MN, MO, NC, NY OH, PA, TN, TX, VA, and WA.

Date initiated

2010-10-02

Date posted

2010-12-27

Date terminated

2011-04-15

Location

Raynham, MA