Z-0577-2008

TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET...

Name: Z-0577-2008 TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET...
Creator: Tenet Medical Engineering Inc
Published: 2007-11-23
License: https://open.fda.gov/license/

Tenet Medical Engineering / initiated 2007-11-23 / Terminated / root cause: packaging

FDA source

Tenet Medical Engineering Inc began a recall of TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3 on 2007-11-23. The reason FDA records is "Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0577-2008
Status: Terminated
Initiated: 2007-11-23
Posted: 2008-02-26
Terminated: 2009-05-01
Recalling firm: Tenet Medical Engineering
Product: TENET Medical Engineering Wrist Stabilization Kit, Small; REF (Part) #7691; Sterile; manufactured by TENET Medical Engineering, Calgary, Alberta, Canada T2Z 4M3.
Product code: JEB Table, Surgical With Orthopedic Accessories, Manual
Reason for recall: Sterility compromised: Sterility seals on some of the firm's wrist stabilization kit pouches may be compromised.
Root cause tag: packaging
FDA 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 in commerce: 300 units.
Distribution: Nationwide Distribution.
Product codes and lots: Lot Number: 20060605.

Product code JEB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)