FDA Device Recall Z-0032-2011: Zimmer Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2011.

Recall Res Number

Z-0032-2011

Recalling Firm / Manufacturer

Zimmer Inc.

FEI Number

1000220733

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2009-01-01

Date Posted

2010-10-08

Date Terminated

2011-01-05

Product Code

KWP

Event Number

54527

Product Quantity

23,205 Units for ALL PRODUCTS IN THIS RECALL

Product Description SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L

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.

Action Details 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.

Distribution Pattern 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.

Code Information / Serial Numbers 10ZG, 12LY, 13XB, 15DZ, 30HP, 36FA, 40EG, 45XB, 7EB.

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Medical Device Recall: Z-0032-2011

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer