Z-3252-2018Class II

Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft...

Name: Z-3252-2018 Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft...
Creator: Zimmer Biomet, Inc.
Published: 2018-08-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2018-08-03 / Terminated / root cause: design

FDA source

Zimmer Biomet, Inc. began a recall of Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in... on 2018-08-03. FDA classified it as Class II and gives the reason as "Expiration date incorrectly listed on the label". 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-3252-2018
Classification: Class II
Status: Terminated
Initiated: 2018-08-03
Posted: 2018-09-26
Terminated: 2020-04-10
Recalling firm: Zimmer GmbH
Product: Biomet Sports Medii cine Juggerknot Long Flex Drill Bit with Sleeve Nitinol intended to be used for soft tissue to bone fixation with indications for use in: Shoulder, Foot and Ankle, Knee, Hand and Wrist and Hip repair.Stainless Steel, Sterile Item Number: 110016992
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: Expiration date incorrectly listed on the label
Root cause tag: design
FDA root cause: Device Design
Action: Zimmer notified distributors on 8/3/18 distributors notified via email. Hospital risk managers, as well as distributors with product, notified via Fed'X. The letter identifies the issue and their responsibilities, locating and removing the product in their territory, as well as identifying hospitals who have fielded inventory. Product to be returned to Zimmer Biomet. Question customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday or to :[email protected]
Quantity in commerce: 217 units
Distribution: AZ CO FL FL GA LA MA MA MO NY SC TX
Product codes and lots: Lot Numbers: 053940, 545740, 067490, 664610, 165770, 676180, 165830, 688250, 415590, 860050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3252-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3252-2018	Class II	Terminated	Voluntary: Firm initiated	2018-10-03	2018-09-26

Product code MBI

K110145Class IIBiomet Sports Medicine Juggerknot Soft AnchorBiomet, Inc. / cleared 2011-03-04

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)