Triathlon MIS 4:1 Cutting Blocks - Size 1-8; Catalog Numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705

FDA device recall Z-1917-2009 · posted 2009-08-26 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.

Action taken

Important Product Correction letters were sent to all branches/agencies on February 12, 2008 by Federal Express. The letter asked consignees to examine their inventory and hospital locations to identify the affected product. Customers were asked to perform a functional inspection by assembling the Triathlon Impactor/Extractor Handle to all of their MIS Cutting Blocks. If the cutting block does not assemble, customers are to list the affected lot codes on the Attached Product Accountability Form and fax a copy to (201) 831-6069. The letter states that product should not be returned until further instructions are received. Questions should be directed to (201) 831-5825.

Root cause

Process control

Status

Terminated

Product code

LXH

Quantity affected

690 - both varieties

Distribution

Worldwide Distribution

Date initiated

2007-02-12

Date posted

2009-08-26

Date terminated

2009-10-15

Location

Mahwah, NJ