Recall Z-1546-2013— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2013-02-14, terminated 2014-05-01. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: The bed frame adapter assemblies may have a weak weld where the patient helper adapter mounting bars attach to the tube..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-02-14
- Terminated
- 2014-05-01
- Firm location
- Warsaw, IN, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.