Z-0777-04

Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156

Name: Z-0777-04 Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156
Creator: Biomet, Inc.
Published: 2004-02-23
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2004-02-23 / Terminated

FDA source

Biomet, Inc. began a recall of Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156 on 2004-02-23. The reason FDA records is "The locking ring was not included and the shoulder implanted without the locking ring". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0777-04
Status: Terminated
Initiated: 2004-02-23
Posted: 2004-07-20
Terminated: 2004-04-13
Recalling firm: Zimmer GmbH
Product: Biomet brand Absolute Bi-Polar Shoulder Shell 48 mm w/locking ring; part 113156.
Product code: KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
Reason for recall: The locking ring was not included and the shoulder implanted without the locking ring.
FDA root cause: Other
Action: The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.
Quantity in commerce: 7
Distribution: California, Florida, Washington, Germany and Venezuela.
Product codes and lots: lot 551440.

Product code KWT

K002998Class IIBiomet Bi-Polar Shoulder SystemBiomet, Inc. / cleared 2000-10-06

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)