Date Initiated by Firm |
March 18, 2015 |
Date Posted |
April 27, 2015 |
Recall Status1 |
Terminated 3 on September 23, 2015 |
Recall Number |
Z-1523-2015 |
Recall Event ID |
70993 |
Product Classification |
Orthopedic manual surgical instrument - Product Code LXH
|
Product |
Anatomical Shoulder Handle for Rasp Item: 01.04233.000
Used during total joint arthroplasty of the shoulder. |
Code Information |
Lot Number(s): 13870129 & 13878179. |
Recalling Firm/ Manufacturer |
Zimmer Gmbh Sulzer Allee 8 Winterthur Switzerland
|
For Additional Information Contact |
Consumer 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 |
Action |
On 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 Commerce |
30 units |
Distribution |
Distributed to the states of IN, GA, WI, MO, PA, KS, TN, and NY. |
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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