Z-1363-2015Class II

ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop...

Name: Z-1363-2015 ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop...
Creator: Biomet, Inc.
Published: 2015-02-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2015-02-26 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of ToggleLoc; fastener, fixation, non degradable, soft tissue; Artificial Ligament Fixation Device #7 PE Ziploop Extended Toggleloc Product Usage: The Toggleloc... on 2015-02-26. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1363-2015
Classification: Class II
Status: Terminated
Initiated: 2015-02-26
Posted: 2015-04-02
Terminated: 2016-01-12
Recalling firm: Zimmer GmbH
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.
Product code: JDR Staple, Fixation, Bone
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.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: 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.
Quantity in commerce: 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.
Product codes and lots: PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1363-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1363-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-01
Z-1364-2015	Class II	Terminated	Voluntary: Firm initiated	2015-04-08	2015-04-01

Product code JDR

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)