Device product
Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive procedure due to injury or degenerative disease
Z-1364-2015
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 70667
- Status
- Terminated
- Classification
- Class II
- Quantity
- 50 Units
- Official record key
device-enforcement:Z-1364-2015
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: 110010873 Lot: 209340
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.