Biomet, Inc.: Medical Device Recall in 2015 - (Recall #: Z-1363-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 26, 2015

Date Posted: April 8, 2015

Recall Number: Z-1363-2015

Event ID: 70667

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.

Status: Terminated

Product Quantity: 50 Units of each

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.

Voluntary or Mandated:

Voluntary: Firm initiated