The Recall Desk
HighFDA (Devices)·Z-1546-2013·Announced 2013-06-26

Zimmer Patient Helper Bed Frame Adapter Assembly Recalled for Weak Welds

Zimmer, Inc. is recalling 344 Patient Helper Bed Frame Adapter Assemblies because they may have a weak weld where the mounting bars attach to the tube.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that poses a risk of harm, but the source text does not report any injuries or illnesses, meeting the criteria for a High severity score.

Plain-English summary

Zimmer, Inc. is recalling 344 units of the Patient Helper Bed Frame Adapter Assembly. The product is intended to be used by qualified medical professionals to adapt a patient helper to a hospital bed, aiding patient mobility and bed ingress and egress.

The recall is due to a potential defect where the weld connecting the patient helper adapter mounting bars to the tube may be weak. The affected units are identified by part number 00-0965-002-01.

The recalled products were distributed nationwide in the United States and in Canada. Consumers and medical professionals should stop using the affected adapter assemblies and contact Zimmer, Inc. for instructions on how to proceed.

The recalled product

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
Manufacturer
Zimmer, Inc.
Affected units
344

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Part number 00-0965-002-01

Distribution

Distributed nationwide across the United States.

The notice also names 23 states specifically: