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U.S. Department of Health and Human Services

Class 2 Device Recall Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control

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 Class 2 Device Recall Comprehensive Shoulder Instruments Fracture Stem Inserter w/Version Controlsee related information
Date Initiated by FirmApril 07, 2011
Date PostedJune 30, 2011
Recall Status1 Terminated 3 on April 08, 2013
Recall NumberZ-2713-2011
Recall Event ID 58544
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductComprehensive Shoulder Instruments Fracture Stem Inserter w/Version Control, REF 31-406901, Biomet Orthopedics Warsaw, IN, Instrument used to introduce the stem into the canal. The instrument is used to insert the shoulder implant into the shoulder.
Code Information 064320, 189990, 293840, 299010, 299020, 401800, 401810, 406610, 444560, 444600, 517880, 517960, 525360, 534260, 657870, 723150 and  727030.
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information ContactMary Johnson
574-372-3983
Manufacturer Reason
for Recall		When the surgeon attempts to remove the inserter from the stem, the inserter may become stuck not allowing it to disengage from the stem. The stem may have to be removed from the patient in order to disengage the inserter from the stem. If the stem is removed from the patient, it could potentially cause a significant delay in the procedure or damage/fracture of the humerus which may require inter
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm, Biomet Orthopedics, sent two "URGENT MEDICAL DEVICE RECALL NOTICE" letters one dated April 7, 2011 and the second letter dated April 12, 2011 which included an additional lot number, to its customers. The letters described the product, problem and actions to be taken. The customers were instructed to immediately locate and discontinue use of the noted product; carefully follow the instructions on the enclosed "FAX Back Response Form"; complete and return the Fax Response Form within three (3) business days via fax to 574-372-1683; use priority carrier for their shipment; If the product was further distributed, they MUST notify and give letter to Hospital personnel, and confirm receipt of this notice by calling, 800-348-9500, extension 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 574-371-3756, Monday through Friday, 8AM to 5PM.
Quantity in Commerce469 both products
DistributionWorldwide distribution: USA (nationwide) including Puerto Rico; and countries of: Australia, Canada, Chile, Columbia, Costa Rica, Italy, Japan, Korea, Netherlands, New Zealand, Spain and Sweden.
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.
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