FDA Medical Device Recalls (openFDA)
Tenet Medical Engineering Inc: TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
- Recall number
- Z-0577-2008
- Recalling firm
- Tenet Medical Engineering Inc
- Product
- TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
- Status
- Terminated
- Initiated
- 2007-11-23
- Posted
- 2008-02-26
- Terminated
- 2009-05-01
- Reason
- Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
- Root cause
- Packaging process control
- Action
- TENET notified US distributor consignee via Urgent Product Recall Notification letter sent FedEx on 11/23/07. Consignee asked to return product and to contact their consignees to also return product.
- Quantity
- 300 units.
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- Lot Number: 20060605.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JEB
- Firm FEI
- 3004750931
- Firm city
- Calgary
- Firm state
- not on file
- Firm country
- Canada
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