Z-1249-2009

Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable...

Name: Z-1249-2009 Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable...
Creator: Synthes Spine
Published: 2008-12-18
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2008-12-18 / Terminated / root cause: manufacturing process

FDA source

Synthes Spine began a recall of Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture... on 2008-12-18. The reason FDA records is "The bender is heating prior to activation of the power button, requiring disassembly to stop heating". 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-1249-2009
Status: Terminated
Initiated: 2008-12-18
Posted: 2009-06-01
Terminated: 2009-12-15
Recalling firm: Synthes GmbH
Product: Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures.
Product code: HRS Plate, Fixation, Bone
Reason for recall: The bender is heating prior to activation of the power button, requiring disassembly to stop heating.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: All affected Synthes CMF Sales Consultants were notified of the Medical Device Recall by phone on 12/19/08 and by letter sent via return receipt email on 12/22/08. All affected hospitals were notified by letter mailed on 12/22/08 via USPS certified mail.
Quantity in commerce: 40 units
Distribution: Nationwide distribution: AL, CA, KS, LA, MD, NJ, NV, NY, OR, PA, TX, and UT
Product codes and lots: Catalog number 530.522S - Lot number TM00324 exp 4/8/10

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)