Device product
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.
Z-0364-2014
Product summary
- Firm
- Biomet, Inc.
- Event
- Event 66639
- Status
- Terminated
- Classification
- Class II
- Quantity
- 25
- Official record key
device-enforcement:Z-0364-2014
Official wording
Reason: 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.
Code information: Catalog:110003173, Lot 127480, 185420, 233500, 233520
Distribution pattern: USA Nationwide Distribution in the states of VA, CA, Ky, and IN
Derived failure modes
-
Unknown
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.