Z-0825-2010

Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S

Name: Z-0825-2010 Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S
Creator: Synthes USA (HQ), Inc.
Published: 2010-01-06
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2010-01-06 / Terminated

FDA source

Synthes USA (HQ), Inc. began a recall of Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S on 2010-01-06. The reason FDA records is "There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0825-2010
Status: Terminated
Initiated: 2010-01-06
Posted: 2010-02-24
Terminated: 2010-10-06
Recalling firm: Synthes GmbH
Product: Synthes In Situ Bender/Cutter Kit-Wide-Sterile. Catalog Number 530.521S.
Product code: HRS Plate, Fixation, Bone
Reason for recall: There is the potential for the bender/cutter attachment to continue heating after release of the power button. There is potential for patient and/or staff injury if continuous heating is unrecognized.
FDA root cause: Other
Action: An "Urgent: Medical Device Recall" letter dated January 8, 2010 was issued to customers via USPS Certified mail. The letter described the issue and affected product. Customers were notified to cease use of the recalled product, examine inventory and follow instructions for return to the firm as indicated in the recall letter. For questions, please call 1-800-620-7025 x 5452 or 1-610-719-5452 or contact your Synthes CMF Sales Consultant.
Quantity in commerce: 187 units
Distribution: Nationwide Distribution.
Product codes and lots: All lots.

Product code HRS

K021458Class IISynthes in-Situ Bender/cutterSynthes (Usa) / cleared 2002-07-24

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

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)