Z-1363-2015 Class II Terminated
FDA device recall Z-1363-2015 was initiated by Biomet, Inc. on Feb 26, 2015 and is designated Class II. Reason for recall: The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not… The recall status is terminated (terminated Jan 12, 2016). Affected quantity: 50 Units of each.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 8, 2015
- Initiation Date
- Feb 26, 2015
- Termination Date
- Jan 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50 Units of each
Product Description
ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc System is a non-resorbable system intended to aid in arthroscopic and orthopedic reconstructive procedures requiring soft tissue fixation, due to injury or degenerative disease.
Reason for Recall
The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed following a standard work process, which resulted in complaints of sterile packaging not being sealed.
Distribution Pattern
Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
Code Information
PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1363-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026