Recall Z-1363-2015
Biomet, Inc. · initiated February 26, 2015
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530
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.
FDA-determined cause: Employee error
Action taken
Biomet sent an Urgent Medical Device Recall Notice letter dated March 4, 2015 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediate locate and discontinued use of the product and its return to Biomet. Customers may contact Field Action Specialist, Regulatory Compliance,at (574) 372-1570.
Details
- Recall number
- Z-1363-2015
- Initiated
- February 26, 2015
- Posted by FDA
- April 2, 2015
- Terminated
- January 12, 2016
- Product code
- JDR – Staple, Fixation, Bone
- Quantity
- 50 Units of each
- Distribution
- Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
- Recalling firm
- Biomet, Inc., Warsaw, IN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1364-2015 Class II | Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to…The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not… | 02/26/2015Terminated |