Z-2399-2012Class II

JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a...

Name: Z-2399-2012 JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a...
Creator: Biomet, Inc.
Published: 2012-08-14
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2012-08-14 / Terminated / root cause: design

FDA source

Biomet, Inc. began a recall of JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm... on 2012-08-14. FDA classified it as Class II and gives the reason as "Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the...". 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-2399-2012
Classification: Class II
Status: Terminated
Initiated: 2012-08-14
Posted: 2012-09-17
Terminated: 2013-04-18
Recalling firm: Zimmer GmbH
Product: JUGGERKNOT INGUIDE PUNCH, 2.9MM. The JuggerKnot 2.9mm In-Guide Punch is intended to be used to prepare a 2.9mm hole into bone in which the JuggerKnot 2.9mm Suture Anchor is to be placed. The JuggerKnot 2.9mm Suture Anchor is intended to be used to attach soft tissue to bone.
Product code: LRY Punch, Surgical
Reason for recall: Investigation found that the current design of the product allows the press-fit of the knob/shaft interface to be overcome by the impaction force of a mallet, causing the knob to potentially unfasten and slide down the shaft.
Root cause tag: design
FDA root cause: Device Design
Action: Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated August 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. A Response Form was included for customers to complete and return via fax to 574-372-1683. Questions related to the recall should be directed to 574-371-3758, Monday through Friday, 8 a.m. to 5 p.m.
Quantity in commerce: 62
Distribution: Nationwide Distribution-including the states of WA, IN, AK, PA, GA, SD, KS, NY, VA, AR, AL, OH, WI, MA, and CA.
Product codes and lots: REF. 912064 LOT 121040, 497540, 839530

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2399-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2399-2012	Class II	Terminated	Voluntary: Firm initiated	2012-09-26	2012-09-17

Product code LRY

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)