Stryker 1) XIA Torque Wrench 2) XIA 3 Torque Wrench 3) XIA Elegance Short Torque Wrench Manufactured by: Stryker Spine S

FDA device recall Z-0375-2014 · posted 2013-11-21 · Terminated

Recall details

Recalling firm

Stryker Spine

Reason for recall

Multiple complaints have reported that the hex tip of the torque wrench fracturing during final tightening.

Action taken

Stryker sent an Urgent Medical Device Removal Notification letter dated September 25, 2013, with product accountability forms to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory and hospital locations to identify any affected product, reconcile any Torque Wrenches with Catalog Number with Lot Numbers referenced in the letter. Customers were asked to fax a copy of the Customer Response Form to Regulatory Compliance at 855-632-9049 or you email it to Spine-RegulatoryActions@Stryker.com. Customers were asked to return the affected product using the enclosed mailing label to: RECALL RA 2013-105 Stryker Spine 59 Route 17 South, Allendale, New Jersey 07401 branches/agencies, the field and surgeons via Fed Ex on starting on 9/24/2013. For questions regarding this recall call 201-760-8298. Stryker sent another Urgent Medical Device Removal Notification Letter dated 1/29/2014 which included additional lots and one product.

Root cause

Process design

Status

Terminated

Product code

LXH

Quantity affected

220 US units; 431 OUS units

Distribution

Worldwide Distribution - USA (nationwide) and Internationally to Argentina, Australia, Canada, Chile, France, Canada, Germany, Hong Kong, Ireland, Italy, Japan, Korea, Netherlands, New Zealand, Spain,

Date initiated

2013-09-24

Date posted

2013-11-21

Date terminated

2016-10-13

Location

Allendale, NJ