Z-0364-2014Class II

Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use

Name: Z-0364-2014 Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use
Creator: Biomet, Inc.
Published: 2013-10-10
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-10-10 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usage: The Juggerknotless Soft Anchors are indicated for soft tissue reattachment... on 2013-10-10. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0364-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-10
Posted: 2013-11-19
Terminated: 2014-07-16
Recalling firm: Zimmer GmbH
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.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
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.
Root cause tag: design
FDA 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 in commerce: 25
Distribution: USA Nationwide Distribution in the states of VA, CA, Ky, and IN
Product codes and lots: Catalog:110003173, Lot 127480, 185420, 233500, 233520

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0364-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0364-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-19

Product code MBI

K123485Class IIJuggerknotless Soft Anchors, Juggerknotless M Soft Anchors, Juggerknotless Soft Anchors with Needles, Juggerknotless SofBiomet Sports Medicine / cleared 2013-03-18

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)