Z-0370-2010

Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001

Name: Z-0370-2010 Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001
Creator: Zimmer Inc.
Published: 2009-05-28
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-05-28 / Terminated

FDA source

Zimmer Inc. began a recall of Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001 on 2009-05-28. The reason FDA records is "The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0370-2010
Status: Terminated
Initiated: 2009-05-28
Posted: 2009-11-19
Terminated: 2011-10-05
Recalling firm: Zimmer GmbH
Product: Zimmer Dynesys top-loading cutter, spacer, Zimmer Spine, Minneapolis, MN; REF 07.01284.001.
Product code: NQP Posterior Metal/Polymer Spinal System, Fusion
Reason for recall: The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
FDA root cause: Other
Action: Consignees were notified by letter dated 5/20/09 titled "Urgent Medical Device Correction" that instructed customers that they may continue to use the recalled product until adequate replacements become available, but that they should always ensure they have a backup spacer cutter (of a different model which does not have this issue) available in case this model should jam during use. Users were also advised to ensure the spacer cutter is properly lubricated and is sharp. For questions, please contact Zimmer Spine at 1-800-777-7505.
Quantity in commerce: 177
Distribution: Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom.
Product codes and lots: All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514.

Product code NQP

K073347Class IIDynesys Top-Loading Spinal SystemZimmer Spine, Inc. / cleared 2008-02-08

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)