Ziploop Button Product Usage: The Ziploop Button is a non-resorbable system intended to aid in ACL reconstructive proced
FDA device recall Z-1364-2015 · posted 2015-04-02 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- JDR
- Quantity affected
- 50 Units
- Distribution
- Worldwide Distribution: US (nationwide) Distribution in the states of:TX, GA, NM, NC and OK and the countries of: Japan, and the Netherlands.
- Date initiated
- 2015-02-26
- Date posted
- 2015-04-02
- Date terminated
- 2016-01-12
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SLEEVE WITH ZIPLOOP FIXATION DEVICES (K101063) | Biomet Sports Medicine | 2010-06-23 |
| BIOMET SPORTS MEDICINE ANCHOR DEVICES AND ZIPLOOP CONSTRUCTS (K080088) | Biomet Manufacturing, Inc. | 2008-06-11 |