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Terminated

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

FDA Recall Z-0777-04 · Posted 2004-07-20

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWT
Date Initiated2004-02-23
Date Terminated2004-04-13
Product Quantity7

Reason for Recall

The locking ring was not included and the shoulder implanted without the locking ring.

Firm Action

The firm recovered the consigneed units from hospital stocks and issued a letter dated 2/23/04 to the two implanting physicians.

Root Cause

Other

Distribution Pattern

California, Florida, Washington, Germany and Venezuela.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002998BIOMET BI-POLAR SHOULDER SYSTEMBiomet, Inc. · 2000-10-06

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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