—#116111

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.

FDA product code: HST — Apparatus, Traction, Non-Powered
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Part number 00-0965-002-01

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Zimmer, Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-02-14
Posted by FDA: 2013-06-14
Terminated: 2014-05-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #116111. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.