FDA Device Recall Z-0030-06: Zimmer Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0030-06.

Recall Res Number

Z-0030-06

Recalling Firm / Manufacturer

Zimmer Inc.

FEI Number

1000220733

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-08-23

Date Posted

2005-10-07

Date Terminated

2005-12-08

Product Code

KWS

Event Number

33279

Product Quantity

N/A

Product Description Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 56 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430605256.

Reason for Recall The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

Action Details Consignees were notified via letter dated August 23, 2005 or by email.

Distribution Pattern Nationwide, Australia, Canada, England, Germany and Italy.

Code Information / Serial Numbers All lots.

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Medical Device Recall: Z-0030-06

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer