Z-0818-2011

Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile

Name: Z-0818-2011 Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile
Creator: DePuy Spine, Inc.
Published: 2010-10-02
License: https://open.fda.gov/license/

DePuy Spine, Inc. / initiated 2010-10-02 / Terminated / root cause: labeling and UDI

FDA source

DePuy Spine, Inc. began a recall of Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw caddy is intended to act as a holder... on 2010-10-02. The reason FDA records is "The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0818-2011
Status: Terminated
Initiated: 2010-10-02
Posted: 2010-12-27
Terminated: 2011-04-15
Recalling firm: DePuy Spine, Inc.
Product: Depuy Spine Mountaineer OCT Spinal System Screw Caddy Set, , Non Sterile Product Code: 2883-90-400 The MOUNTAINEER Screw caddy is intended to act as a holder in an implant set for implantable screws prior to use in surgery. Further, the caddy provides a means to organize the screws in accordance with the length of the screws.
Product code: LRP Tray, Surgical
Reason for recall: The scale which serves as a secondary means of identifying screw length is incorrectly etched on the screw caddy
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: Not lot coded

Product code LRP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)