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Class 2 Device Recall |
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Date Initiated by Firm |
June 18, 2003 |
Date Posted |
September 24, 2003 |
Recall Status1 |
Terminated 3 on September 23, 2003 |
Recall Number |
Z-1286-03 |
Recall Event ID |
26618 |
510(K)Number |
K911684
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Product Classification |
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented - Product Code JDI
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Product |
Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251 |
Code Information |
lots 267824, 292736, 336747, 348666, 351182, 351944, 358183, 361071, 366677, 375324, 376152, 396782, 424534, 424535, 438547, 469956, 497678, 095912 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 East Bell Drive Warsaw IN 46582
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For Additional Information Contact |
800-348-9500 Ext. 1305
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Manufacturer 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.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
28 |
Distribution |
United States |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = JDI and Original Applicant = BIOMET, INC.
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