ToggleLoc — Class II medical device recall Z-1363-2015
Terminated recall by Biomet, Inc., reported 2015-04-08, distributed nationwide. The firm is recalling ToggleLocs and Ziploops manufactured in May and July of 2014 as they were not processed
| Recall number | Z-1363-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Biomet, Inc., Warsaw, IN, United States |
| Recall initiated | 2015-02-26 |
| Classified | 2015-04-01 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2016-01-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | JP, NL |
| Quantity | 50 units |
| Reason classes | sterility |
| Lot numbers | 019150, 729530, 909848 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1363-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.