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Terminated

Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242

FDA Recall Z-1282-03 · Posted 2003-09-24

Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeJDI
Date Initiated2003-06-18
Date Terminated2003-09-23
Product Quantity5

Reason for Recall

The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.

Firm Action

Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.

Root Cause

Other

Distribution Pattern

United States

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K911684BIOMET COBALT-CHROME FEMORAL COMPONENTSBiomet, Inc. · 1991-06-27

Official Source

View FDA Recall →

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

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