Stryker Orthopaedics Triathlon Femoral Distal Augment- Left; 1 single unit per package Howmedica Osteonics Corp. 325 Cor

FDA device recall Z-1370-2013 · posted 2013-05-23 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Stryker Orthopaedics received a report that a label on the external packaging (box) of a Triathalon Femoral Distal Augment 10mm- Size 5 Left depicted a glyph of an acetabular shell rather than a femoral distal augment. In addition the label was missing a reference to the "10mm" augment thickness which per the label print is required to appear below the size reference.

Action taken

The firm, Stryker Orthopaedics, sent an "URGENT MEDICAL DEVICE REMOVAL" letter dated March 25, 2013 and Product Accountability Forms via Fed Ex to its Consignees/ customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete and return the attached Notification Acknowledgment Form within 5 days via fax to 855-251-3635; contact the hospitals in your territory that have the affected product to arrange return of product; and return affected product to the attention of Regulatory Compliance Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430, attach flourescent orange PRODUCT REMEDIATION sticker to your return indicating the PR #RA2013-011 and mark outer box with the words "Product Recall". If you have any questions, feel free to contact Manager, Divisional Regulatory Compliance at (201) 972-2100.

Root cause

Software design

Status

Terminated

Product code

JWH

Quantity affected

11 units

Distribution

Nationwide distribution: USA including states of: HI, IN, MS, NC, NJ, OK, TX, and WI.

Date initiated

2013-03-25

Date posted

2013-05-23

Date terminated

2015-05-06

Location

Mahwah, NJ

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