FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: 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, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile: Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
- Recall number
- Z-1917-2009
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- 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, 6541-5-706, 6541-5-707, & 6541-5-708; Triathlon MIS Instruments; Non Sterile: Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 The Triathlon AR 4:1 Cutting Blocks and the Triathlon MIS 4:1 Cutting Blocks are used to prepare the Femur (bone cuts) for the Triathlon femoral component.
- Status
- Terminated
- Initiated
- 2007-02-12
- Posted
- 2009-08-26
- Terminated
- 2009-10-15
- Reason
- Triathlon Cutting Blocks did not assemble to the Triathlon Impactor/Extractor Handle.
- Root cause
- Process control
- Action
- 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.
- Quantity
- 690 - both varieties
- Distribution
- Worldwide Distribution
- Lot, serial or model codes
- Catalog numbers: 6541-5-701, 6541-5-702, 6541-5-703, 6541-5-704, 6541-5-705, 6541-5-7-6, 6541-5-707, 6541-5-708. All lot codes.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28