Recall Z-0364-2014— Biomet, Inc.

Name: FDA recall Z-0364-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-10

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2013-10-10, terminated 2014-07-16. It names one FDA 510(k) clearance: K123485. 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.. 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..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Terminated: 2014-07-16
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K123485 — JUGGERKNOTLESS SOFT ANCHORS, JUGGERKNOTLESS M SOFT ANCHORS, JUGGERKNOTLESS SOFT ANCHORS WITH NEEDLES, JUGGERKNOTLESS SOFBiomet Sports Medicine·cleared 2013-03-18

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.