Biomet, Inc.: 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.

Recall number

Z-0364-2014

Recalling firm

Biomet, Inc.

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.

Status

Terminated

Initiated

2013-10-10

Posted

2013-11-19

Terminated

2014-07-16

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.

Root cause

Device Design

Action

Biomet sent an Urgent Medical Device Recall Notice letter dated October 10, 2013 to all consignees. The letter identified the affected product, reason for recall, and actions to be taken. The letter stated customers will be contacted on an individual basis in an attempt to reconcile the affected product. Customers were directed to locate and remove implicated devices and fax a copy of the response form to 574-372-1683 prior to returning product. For questions call 574-372-1570.

Quantity

25

Distribution

USA Nationwide Distribution in the states of VA, CA, Ky, and IN

Lot, serial or model codes

Catalog:110003173, Lot 127480, 185420, 233500, 233520

510(k) numbers

["K123485"]

PMA numbers

not on file

Product code

MBI

Firm FEI

1825034

Firm city

Warsaw

Firm state

IN

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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