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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 Device Recall Zimmer Patient Helper Bed Frame Adapter Assemblysee related information
Date Initiated by FirmFebruary 14, 2013
Date PostedJune 14, 2013
Recall Status1 Terminated 3 on May 01, 2014
Recall NumberZ-1546-2013
Recall Event ID 64424
Product Classification Apparatus, traction, non-powered - Product Code HST
ProductZimmer 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 IN 46580-2746
For Additional Information ContactAngel 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		Device Design
ActionZimmer 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 Commerce344 Units
DistributionWorldwide 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 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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