Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Anatomical Shoulder Handle for Rasp

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Zimmer Anatomical Shoulder Handle for Rasp see related information
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
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.
-
-