Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in Ireland. Howmedica Osteonics 325 Corporate Drive

FDA device recall Z-2334-2010 · posted 2010-08-31 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

A lot for lot mix up occurred between the Triathlon Total Knee System Primary Tibial Baseplate # 4 Cemented, Catalog # 5520-B-400, Lot SH8NT and the #2 Cemented, Catalog # 5520-B-200, Lot SH7RP.

Action taken

The firm, Stryker Orthopaedics, sent an "URGENT PRODUCT RECALL" letter dated September 1, 2009, via FedEx to all customers. The letter described the product, problem and action to be taken by customers. The customers were instructed to examine their inventory and hospital locations to identify the affected product; retrieve and return all affected products via Inter-Org Transfer and ship to Stryker Orthopaedics, 325 Corporate Drive, Mahwah, New Jersey, 07430; Attn: Regulatory Reporting, and attach the fluorescent orange PRODUCT REMEDIATION sticker and mark the outer box with the words "PRODUCT RECALL; complete and fax the attached Product Accountability Form and spreadsheet to (201) 831-6069 within 5 days of receipt of the notice. If you have any questions, please contact the Manager, Divisional Regulatory Reporting at (201) 831-5970.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

JWH

Quantity affected

Lot Code: SH7RP - 6 in the US. Lot Code SH8NT was not received in the US.

Distribution

Nationwide distribution: AL, AZ, CA, MT, NJ and TX.

Date initiated

2009-09-01

Date posted

2010-08-31

Date terminated

2012-08-27

Location

Mahwah, NJ

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