Depth Gauge; Catalog Number: 703707; Stryker Trauma AG, CH 2545 Selzach; Distributed in USA by Howmedica Osteonics Corp.

FDA device recall Z-0796-2010 · posted 2010-02-19 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.

Action taken

Urgent Product Recall letters, dated December 22, 2009, were sent to all Stryker Branches/Agencies. Letters were also sent to hospitals and surgeons that use the VariaAx Elbow System were also notified. All letters were sent by Federal Express. The letters identified the affected product, stated the issue, and the hazards involved. It also asked customers to examine their inventory and hospital locations to identify affected products. All affected products are to be retrieved and returned to their branch or agency warehouse for reconciliation. All products should be reconciled on the attached Product Accountability Form and a copy should be faxed to 201-831-6069 within 5 days of receipt of the notice. Follow the instructions for shipping the affected product back to the firm. Questions should be directed to 201-972-2100.

Root cause

Process control

Status

Terminated

Product code

HTJ

Quantity affected

49

Distribution

Nationwide Distribution

Date initiated

2009-12-22

Date posted

2010-02-19

Date terminated

2010-03-16

Location

Mahwah, NJ