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U.S. Department of Health and Human Services

Class 2 Device Recall OSS AVL Poly Tibial Bushing Set

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 Class 2 Device Recall OSS AVL Poly Tibial Bushing Setsee related information
Date Initiated by FirmFebruary 07, 2012
Date PostedMarch 02, 2012
Recall Status1 Terminated 3 on February 06, 2013
Recall NumberZ-1143-2012
Recall Event ID 61100
510(K)NumberK062997 
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
ProductOSS AVL Poly Tibial Bushing Set OSS AVL Tibial Bushings are designed to hold the anti-lux yoke in place for OSS procedures.
Code Information Lot numbers861280, 294060, and 723610
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		Biomet initiated this action after complaints were received where OOS AVL Bushing Sets were opened during OSS knee replacement procedures, and were found to contain two tabbed bushings.
FDA Determined
Cause 2		Employee error
ActionBIOMET Orthopedics sent an URGENT MEDICAL DEVICE recall notice dated February 7, 2012, to all affected consignees. The recall notice instructed consignees to immediate locate and remove the devices from circulation and to fax back the response form to 574-372-1683. If product was further distributed, consignees must notify hospital personnel of this action via the enclosed notice. Consignees were charged with the location and return of the affected product. For questions regarding this recall call 574-372-3983 or 574-371-3009.
Quantity in Commerce27 units distributed US and foreign
DistributionWorldwide Distribution - USA including IN. KS, NJ, CA, and OH Internationally: The Netherlands
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LZO
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