| | Class 2 Device Recall Biomet Orthopedics Apical Hole Plug |  |
| Date Initiated by Firm | August 09, 2007 |
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| Date Posted | October 27, 2007 |
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| Recall Status1 |
Terminated 3 on June 26, 2009 |
| Recall Number | Z-0102-2008 |
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| Recall Event ID |
44812 |
| Product Classification |
Apical Hole Plug - Product Code LPH
|
| Product | Biomet Orthopedics Apical Hole Plug, 3/8 - 24 threaded, TI-6AL-4V alloy, sterile; REF 123741, Biomet Orthopedics, Inc., Warsaw, IN 46581 |
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| Code Information |
Lot 522080. |
Recalling Firm/
Manufacturer |
Biomet, Inc.
56 E Bell Dr
Warsaw IN 46581-0587
|
| For Additional Information Contact | Paula Richardson
800-348-9500 |
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Manufacturer Reason
for Recall | Incorrect or lack of threading: The plug component was manufactured incorrectly and does not fit with the screw hole as intended. |
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FDA Determined
Cause 2 | Process control |
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| Action | The distributor was notified via phone on or about 8/9/07 and by letter dated 8/31/07 and requested to return the product. Returns included subaccounts |
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| Quantity in Commerce | 5 |
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| Distribution | Nationwide |
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| 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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