FDA Medical Device Recalls (openFDA)
Howmedica Osteonics Corp.: T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
- Recall number
- Z-0994-04
- Recalling firm
- Howmedica Osteonics Corp.
- Product
- T2 Proximal Humeral System Targeting Arm. Catalog number 1806-2035.
- Status
- Terminated
- Initiated
- 2004-03-31
- Posted
- 2004-07-20
- Terminated
- 2004-06-03
- Reason
- Targeting device may become distorted upon repeated autoclaving.
- Root cause
- Other
- Action
- On March 31, 2004 recall letters and product accountability forms were sent via FedEx.
- Quantity
- 32 devices
- Distribution
- There were 19 consignees which are Stryker sales representatives and subsidiaries nationwide.
- Lot, serial or model codes
- Lot Code: K589039; K658262; K658259; K74990; K766542.
- 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