Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by qualified medi

FDA device recall Z-1546-2013 · posted 2013-06-14 · Terminated

Recall details

Recalling firm

Zimmer, Inc.

Reason for recall

The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

HST

Quantity affected

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.

Date initiated

2013-02-14

Date posted

2013-06-14

Date terminated

2014-05-01

Location

Warsaw, IN