Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241
Brand
Biomet, Inc.
Lot Codes / Batch Numbers
lots 323846, 342260, 352799, 377954, 404867, 434003, 442086, 442087, 442088, 448410, 469963, 469966
Products Sold
lots 323846, 342260, 352799, 377954, 404867, 434003, 442086, 442087, 442088, 448410, 469963, 469966
Biomet, Inc. is recalling Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241 due to The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026