Z-1399-2010

Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011...

Name: Z-1399-2010 Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011...
Creator: Orthohelix Surgical Designs Inc
Published: 2009-10-16
License: https://open.fda.gov/license/

TORNIER Inc. / initiated 2009-10-16 / Terminated

FDA source

Orthohelix Surgical Designs Inc began a recall of Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used... on 2009-10-16. The reason FDA records is "The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1399-2010
Status: Terminated
Initiated: 2009-10-16
Posted: 2010-04-15
Terminated: 2012-04-11
Recalling firm: TORNIER Inc.
Product: Quick Connect Adapter Model #CSS-QA-Adapter MaxTorque(R) Maxtorque Quick Connect Lot #s: 1014001 & 1101011, QTY 1 NON STERILE MAT:17-4PH The intended use: Used to stabilize and aid in the fixation of fractures, fusions, and osteotomies.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: The adapters are able to come apart when a retaining ring in the proximal end of the adapter can dislodge from the retaining ring groove and the two ends of the adapter fall apart and are unable to be reassembled without special tools and knowledge of the instrument. Also the adapters have a wobble between the two ends. This is caused when the distal and proximal ends of the adapter assembly were
FDA root cause: Other
Action: Two "IMPORTANT RECALL NOTICE" letters, one dated October 16, 2009, and the second letter dated November 19, 2009, were sent to the customers. The letters described the product, problem and action to be taken by the customers. The customer are requested to discontinue use of the adapters and return them to the firm, Orthohelix Surgical Designs. The firm will replace the adapters as soon as possible. Should you have any questions about the systems please contact Kristin Wolff at 330-247-1445 or Jim Bragg at 330-247-1444.
Quantity in commerce: 127 pieces
Distribution: Nationwide distribution: CA, CO, FL, GA, IL, KY, MD, MI, MO, MS, NC, NJ, NM, NY, OH, OR, PA, SD, TN, TX, VA, WA , and WI.
Product codes and lots: Model #CSS-QA-Adapter Lot #: GB759, GB-924, 1014001 & 1101011

Product code LXH

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)