Z-2104-2016 Class II Terminated
FDA device recall Z-2104-2016 was initiated by Medical Depot Inc. on Feb 17, 2016 and is designated Class II. Reason for recall: Tip crutch failure involving the bottom of the metal portion which comes in contact with ground The recall status is terminated (terminated Jun 13, 2018). Affected quantity: 123,125 pairs.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 6, 2016
- Initiation Date
- Feb 17, 2016
- Termination Date
- Jun 13, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 123,125 pairs
Product Description
Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case Aid the user in walking while relieving weight from one foot or leg.
Reason for Recall
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Distribution Pattern
Nationwide Distribution
Code Information
Item #: 1) RTL 10400, 2) RTL 10402