Z-0031-2011

SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M

Name: Z-0031-2011 SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M
Creator: Zimmer Inc.
Published: 2009-01-01
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-01-01 / Terminated / root cause: labeling and UDI

FDA source

Zimmer Inc. began a recall of SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M on 2009-01-01. The reason FDA records is "The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added...". 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-0031-2011
Status: Terminated
Initiated: 2009-01-01
Posted: 2010-10-08
Terminated: 2011-01-05
Recalling firm: Zimmer GmbH
Product: SpeedLink 6.0 Transverse Connector Medium 43-51mm, non-sterile, 1304-60M
Product code: KWP Appliance, Fixation, Spinal Interlaminal
Reason for recall: The firm received complaints that the device was damaged or fractured while the surgeon was bending it prior to implantation. There were also complaints that the cam may dislodge during tightening. The firm added additional instructions for use to reduce the probability of these two types of events.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The firm provided a revised surgical technique document to the Zimmer spine sales force in January, 2009. The firm will provide an Urgent Medical Device Correction notification to speedlink users through the sales force.
Quantity in commerce: 23,205 Units for ALL PRODUCTS IN THIS RECALL
Distribution: The devices are contained in implant cases stocked by Zimmer spine and made available to the Zimmer sales force for surgeries. They are not in general distribution.
Product codes and lots: 14MM, 15EE, 27LL, 35HR, 41HC, 45XA, 7EA, 8BQ and 9FZ.

Product code KWP

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)