Z-0364-2014 Class II Terminated
FDA device recall Z-0364-2014 was initiated by Biomet, Inc. on Oct 10, 2013 and is designated Class II. Reason for recall: Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion. The recall status is terminated (terminated Jul 16, 2014). Affected quantity: 25.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 27, 2013
- Initiation Date
- Oct 10, 2013
- Termination Date
- Jul 16, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25
Product Description
Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment procedures in the shoulder, foot/ankle, hand/wrist, and hip.
Reason for Recall
Investigation identified that the design of the drill bit may make the suture anchor difficult to insert into the bone. The implant may skip across the hole or miss the hole during insertion.
Distribution Pattern
USA Nationwide Distribution in the states of VA, CA, Ky, and IN
Code Information
Catalog:110003173, Lot 127480, 185420, 233500, 233520
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0364-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026