Z-1546-2013Class II

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

Name: Z-1546-2013 Zimmer Patient Helper Bed Frame Adapter Assembly The bed frame adapter assembly is intended to be used by...
Creator: Zimmer, Inc.
Published: 2013-02-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-02-14 / Terminated / root cause: design

FDA source

Zimmer, Inc. began a recall of 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... on 2013-02-14. FDA classified it as Class II and gives the reason as "The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1546-2013
Classification: Class II
Status: Terminated
Initiated: 2013-02-14
Posted: 2013-06-14
Terminated: 2014-05-01
Recalling firm: Zimmer GmbH
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.
Product code: HST Apparatus, Traction, Non-Powered
Reason for recall: The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
Root cause tag: design
FDA root cause: 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 [email protected]. 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.
Product codes and lots: Part number 00-0965-002-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1546-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1546-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-26	2013-06-14

Product code HST

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)