Device product
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.
Z-1363-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 70667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 Units of each
- Official record key
device-enforcement:Z-1363-2015
Official wording
Reason: 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.
Code information: PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530
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.
Derived failure modes
-
Unknown
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.