—#134383

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.

FDA product code: JDR — Staple, Fixation, Bone
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K130033, K141263
Affected lot / code info: PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530

Why it was recalled

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.

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

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.

Timeline

Recall initiated: 2015-02-26
Posted by FDA: 2015-04-02
Terminated: 2016-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #134383. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.