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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Patient Helper Bed Frame Adapter Assembly

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 Class 2 Recall
Zimmer Patient Helper Bed Frame Adapter Assembly
see related information
Date Posted June 14, 2013
Recall Status1 Terminated on May 01, 2014
Recall Number Z-1546-2013
Recall Event ID 64424
Product Classification Apparatus, Traction, Non-Powered - Product Code HST
Product Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed. The patient helper is used to aid and assist the patient's mobility within a hospital bed and during bed ingress and egress.
Code Information Part number 00-0965-002-01
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Angel Estrada
866-201-9081
Manufacturer Reason
for Recall
The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
FDA Determined
Cause 2
DESIGN: Device Design
Action Zimmer sent an Urgent Device Removal letter dated February 14, 2013, to all affected consignees. The letter identified the product, the problem,and the action to be taken by the consignee. Consignees were advised to review the notification letter, follow the instructions contained in the letter, remove from use and quarantine the affected product. Consignees were also instructed to complete and return the fax back from to 877-787-0375 or zimmer3632@stericycle.com. Consignees were instructed to return the affected product back using the shipping label provided. If affected product was further distribution, consignees were asked to provide the customer's information to the firm on the back of the form. For questions regarding this recall call 866-201-9081.
Quantity in Commerce 344 Units
Distribution Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, CT, FL, HI, IL, KY, MA, MD, MN, MO, NE, NJ, NY, OH, OK, PA, TN, TX, WA, and WI; and country of Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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