Z-0054-2013Class II

TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers...

Name: Z-0054-2013 TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers...
Creator: Kardium
Published: 2012-08-28
License: https://open.fda.gov/license/

KARDIUM Inc. / initiated 2012-08-28 / Terminated / root cause: manufacturing process

FDA source

Kardium began a recall of TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device... on 2012-08-28. FDA classified it as Class II and gives the reason as "The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0054-2013
Classification: Class II
Status: Terminated
Initiated: 2012-08-28
Posted: 2012-10-11
Terminated: 2013-02-05
Recalling firm: KARDIUM Inc.
Product: TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This product is used to close the sternal wires during cardiac surgery, and it is not an implantable device. The TORQ Sternal Closure device is used during sternal closure to tension and twist standard stainless steel surgical sutures of USP size 6 or 7 (metric size 8.0 or 9.0). The TORQ device is designed for use as a standard surgical suture wire twister for sternal closure. (Surgical sutures are not provided with the device.) The TORQ device is disposable, single-use, non-implantable and supplied sterile.
Product code: HXS Twister, Wire
Reason for recall: The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Kardium Inc. sent an "URGENT: TORQ STERNAL CLOSURE DEVICE RECALL" e-mailed dated August 30, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. The letter instructs customers to discontinue use of the TORQ Sternal Closure Device lot 062711 immediately. Contact the firm at 604-248-8891, x285 for any questions about this recall.
Quantity in commerce: 480 units
Distribution: Nationwide Distribution-including the states of FL, GA, IL, and NH.
Product codes and lots: Lot No. 062711. Expiry date is June 2014.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0054-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0054-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-17	2012-10-11

Product code HXS

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)