| Class 2 Device Recall Oxford Unicompartmental Toffee Hammer | |
Date Initiated by Firm | March 20, 2013 |
Date Posted | April 15, 2013 |
Recall Status1 |
Terminated 3 on May 04, 2015 |
Recall Number | Z-1124-2013 |
Recall Event ID |
64679 |
Product Classification |
Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing - Product Code NRA
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Product | REF 32-422760
Oxford Uni Knee System,Toffee Hammer, non-sterile,
found in REF 32-422763 Oxford Mlcroplasty Knee System
Tibial instrument Tray
small surgical hammer supplied with the Oxford Partial Knee Microplasty Instrument set, used for impacting implants. |
Code Information |
32-422760 ( sold as part of instrument set 32-422763 ) ZB100901,ZB110201,ZB110301,ZB110302,ZB110303, ZB110304,ZB110601,ZB110602,ZB110701,ZB111201, ZB111202,ZB120201,ZB120202,ZB120701,ZB120801, ZB120802,ZB121102,ZB121103 |
Recalling Firm/ Manufacturer |
Biomet U.K., Ltd. Waterton Industrial Estate Bridgend South Wales United Kingdom
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Manufacturer Reason for Recall | Investigation of complaints found excessive use of the instrument could result in cracking on the weld between the head and the handle, which could lead to part of the head becoming detached from the handle. |
FDA Determined Cause 2 | Device Design |
Action | BIOMET sent an Urgent Medical Device Recall Notice on March 20, 2013, to all affected customers with directions to forward the notice if product was further distributed to Hospital Operating Room managers. The notice identified the recalled device, reason for the recall, and possible adverse events directing consignees to locate and discontinue use of the device. A FAX back Response form was to be returned to 574-372-1683 within 3 days of receipt prior to return of the product to Biomet, USA. Questionsregarding this recall should be addressed to 574 372-1570 M-F, 8a.m. -5 p.m. |
Quantity in Commerce | 430 |
Distribution | Worldwide Distribution - USA (nationwide), Europe, Japan, Australia, Canada, Singapore, South Africa, and Costa Rica. |
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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