Z-1546-2013 Class II Terminated
FDA device recall Z-1546-2013 was initiated by Zimmer, Inc. on Feb 14, 2013 and is designated Class II. Reason for recall: The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube. The recall status is terminated (terminated May 1, 2014). Affected quantity: 344 Units.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 26, 2013
- Initiation Date
- Feb 14, 2013
- Termination Date
- May 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 344 Units
Product Description
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.
Reason for Recall
The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube.
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.
Code Information
Part number 00-0965-002-01
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1546-2013
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026