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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Anatomical Shoulder Handle for Rasp

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 Class 2 Device Recall Zimmer Anatomical Shoulder Handle for Raspsee related information
Date Initiated by FirmMarch 18, 2015
Date PostedApril 27, 2015
Recall Status1 Terminated 3 on September 23, 2015
Recall NumberZ-1523-2015
Recall Event ID 70993
Product Classification Orthopedic manual surgical instrument - Product Code LXH
ProductAnatomical Shoulder Handle for Rasp Item: 01.04233.000 Used during total joint arthroplasty of the shoulder.
Code Information Lot Number(s):  13870129 &  13878179.
FEI Number 3005233524
Recalling Firm/
Manufacturer		 Zimmer Gmbh
Sulzer Allee 8
Winterthur Switzerland
For Additional Information ContactConsumer Relations Call Center
877-946-2761
Manufacturer Reason
for Recall		Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionOn 3/18/2015, URGENT MEDICAL DEVICE RECALL Notification - LOT SPECIFIC letters were sent to the affected distributors with instructions for locating, quarantining, and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-877-946-2761 between 8:00 am and 5:00pm EST.
Quantity in Commerce30 units
DistributionDistributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY.
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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