| Class 2 Device Recall A.L.P.S. Clavicle Plating System | |
Date Initiated by Firm | December 23, 2020 |
Date Posted | January 21, 2021 |
Recall Status1 |
Terminated 3 on April 13, 2023 |
Recall Number | Z-0882-2021 |
Recall Event ID |
87095 |
510(K)Number | K173767 |
Product Classification |
Plate, fixation, bone - Product Code HRS
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Product | A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bone. |
Code Information |
Item: 233500004; Lot: 516349, 545167; UDI: (01)0088030483464(10)516349, (01)00880304834644(11)190208(10)545167 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact | 574-372-1687 |
Manufacturer Reason for Recall | The instruments may become cold welded together when the drill is inserted through the Soft Tissue Guide. This prevents disassociation of the instruments and potentially leads to an increased chance of fracture of the drill. |
FDA Determined Cause 2 | Device Design |
Action | On 12/30/2020, Zimmer Biomet issued an Urgent Medical Device Recall to the consumer/user level, including any intermediate wholesale or retail consignees. All distributors will be notified via email. Hospital risk managers and surgeons, as well as distributors with product, will be notified via courier. |
Quantity in Commerce | 174 systems |
Distribution | Nationwide distribution. |
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 = HRS
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