FDA Medical Device Recalls (openFDA)
Stryker Instruments, Instruments Div.: Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
- Recall number
- Z-0171-04
- Recalling firm
- Stryker Instruments, Instruments Div.
- Product
- Stryker brand OrthoTec pulsed irrigation/suction handpiece and tubing set; part number 0203-020-000.
- Status
- Terminated
- Initiated
- 2003-11-12
- Posted
- 2004-07-20
- Terminated
- 2004-05-03
- Reason
- Product sterility may have been compromised by an inadequate package seal.
- Root cause
- Other
- Action
- Recall letters dated 11/12/03 were issued to each customer and sales representatives were requested to question each account about affected product.
- Quantity
- 15
- Distribution
- United States, France and United Kingdom.
- Lot, serial or model codes
- Lots 03082022, 03082042, 0308102, 03082122, 03082162, 03082202, 03082222, 03092242, 03092302, 03092322, 03092342, 03092402, 03092422, 03092442 and 03092462.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPK
- Firm FEI
- 1811755
- Firm city
- Kalamazoo
- Firm state
- MI
- 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