ToggleLoc recallZ-1363-2015 · Biomet, Inc. · initiated Feb 26, 2015
Class II Terminated All recalls posted in April 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Biomet, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Employee error
What the company is doing
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.
Recall details
- Recall number
- Z-1363-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 26, 2015
- Posted by the FDA
- Apr 2, 2015
- Recalling firm
- Biomet, Inc.
- Quantity
- 50 Units of each
- Product code
- JDR
- FDA submissions
- K130033, K141263
- 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 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.
Code information (models, lots, serial numbers)
PN: 904755 Lot: 019150 & PN: 909848 Lot: 729530
Other devices under the same FDA submission
16 devices cleared under K130033, K141263 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ZIPTIGHT FIXATION SYSTEM 904759Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall23 reports
- ZIPTIGHT 904834Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE1 recall9 reports
- JuggerLoc™JuggerLoc™ Slotted Reamer 110018275Biomet Orthopedics, LLC · Fastener, fixation, nondegradable, soft tissue1 recall0 reports
- JuggerLoc™JuggerLoc™ Slotted Reamer 110010372Biomet Orthopedics, LLC · Fastener, fixation, nondegradable, soft tissue1 recall0 reports
- JuggerLoc™JuggerLoc™ Slotted Reamer 110010373Biomet Orthopedics, LLC · Fastener, fixation, nondegradable, soft tissue1 recall0 reports
- JuggerLoc™ 110010371Biomet Orthopedics, LLC · Staple, fixation, bone1 recall0 reports
- ZIPTIGHT FIXATION SYSTEM 909853Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE15 reports
- TOGGLELOC XL WITH ZIPLOOP INLINE 110005090Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE4 reports
- ToggleLoc With Ziploop 904755Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE3 reports
- ToggleLoc With Ziploop 904754Biomet Orthopedics, LLC · STAPLE, FIXATION, BONE3 reports
- ZIPTIGHT FIXATION SYSTEM 909856Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE3 reports
- TOGGLELOC XL WITH ZIPLOOP 110005089Biomet Orthopedics, LLC · FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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