FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics: T2 4.2mmx130mm Tri Flat Bit
- Recall number
- Z-0585-03
- Recalling firm
- Stryker Howmedica Osteonics
- Product
- T2 4.2mmx130mm Tri Flat Bit
- Status
- Terminated
- Initiated
- 2003-01-20
- Posted
- 2003-02-26
- Terminated
- 2003-05-06
- Reason
- Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
- Root cause
- Other
- Action
- Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
- Quantity
- 1
- Distribution
- Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
- Lot, serial or model codes
- 1806-4285S T2 4.2mmx130mm Tri Flat Bit -- K727627; K727628; K727630; K823224; K823225; K824691; K824692; K824693.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- HTW
- 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