Z-1348-2009

Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion...

Name: Z-1348-2009 Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion...
Creator: Synthes Spine
Published: 2009-02-10
License: https://open.fda.gov/license/

Synthes GmbH / initiated 2009-02-10 / Terminated / root cause: labeling and UDI

FDA source

Synthes Spine began a recall of Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide on 2009-02-10. The reason FDA records is "Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1348-2009
Status: Terminated
Initiated: 2009-02-10
Posted: 2009-06-10
Terminated: 2009-10-05
Recalling firm: Synthes GmbH
Product: Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide.
Product code: ODP Intervertebral Fusion Device With Bone Graft, Cervical
Reason for recall: Tip breakage, due to inadequate instructions for use. The Technique Guide provided incorrect information related to use of the Torque Limiting Attachment during screw insertion and final tightening.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: All affected Synthes Spine Sales Consultants were notified of the Labeling Correction via email on February 10, 2009. They were instructed to review changes with their surgeons. They were supplied with an electronic version of the corrected Technique Guide on March 11, 2009. All affected Synthes Sales Consultants and Customers were notified of this labeling change via distribution of the updated Technique Guide and a notification letter. This packet was sent via USPS certified mail on March 26, 2009. To ensure a broad and accurate distribution of notification, affected consultants and customers are defined as having been shipped Zero-P 3.0 mm Titanium Cervical Spine Locking Screws. These devices are used only with the Zero-P system.
Quantity in commerce: 1766 units
Distribution: Distributed Nationwide and Canada.
Product codes and lots: Catalog # 03.617.902 - All lots

Product code ODP

K072981Class IISynthes Zero-PSynthes Spine Co.Lp / cleared 2008-02-11

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)