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U.S. Department of Health and Human Services

Class 2 Device Recall A.L.P.S

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  Class 2 Device Recall A.L.P.S see related information
Date Initiated by Firm June 04, 2015
Date Posted July 08, 2015
Recall Status1 Terminated 3 on December 22, 2015
Recall Number Z-2046-2015
Recall Event ID 71511
510(K)Number K093474  K111663  
Product Classification Plate, fixation, bone - Product Code HRS
Product A.L.P.S. Foot Locking Calcaneus Plate,Small-Right.

Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
Code Information Part Number: 816209001; Lots: 015840, 124980, 948210 and P0059, P0076, or P0061 will be etched on the plate itself.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639
Manufacturer Reason
for Recall		 The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers.
FDA Determined
Cause 2		 Process change control
Action On June 4, 2015 an URGENT MEDICAL DEVICE REMOVAL letter was sent to all consignees. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation; Carefully follow the instructions on the enclosed "Response Form"; Email a copy of the Response Form to audrey.daenzer@biomet.com prior to return of product; Use priority carrier for your shipment; and If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear Risk/Recall Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products. Please confirm receipt of this notice by sending back the response form within three (3) business days. Thank you in advance for your assistance and prompt attention. On behalf of Biomet, I apologize for any inconvenience this may cause. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in Commerce 75 units
Distribution Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands.
Total Product Life Cycle TPLC Device Report
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.
510(K) Database 510(K)s with Product Code = HRS and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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