Z-1376-2013Class II

NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in...

Name: Z-1376-2013 NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in...
Creator: Zimmer, Inc.
Published: 2013-03-27
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2013-03-27 / Terminated / root cause: manufacturing process

FDA source

Zimmer, Inc. began a recall of NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia on 2013-03-27. FDA classified it as Class II and gives the reason as "Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1376-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-27
Posted: 2013-05-24
Terminated: 2017-01-26
Recalling firm: Zimmer GmbH
Product: NEXGEN Complete Knee Solution Monoblock Tibial Drill with stop 10.7 mm. Used to prepare cylindrical holes in the native tibia.
Product code: HTW Bit, Drill
Reason for recall: Zimmer is initiating a lot specific recall of the Trabecular Metal" Tibia Stop Drill due to the potential of the outside diameter being oversized. As a result, there is a potential for the drill to not pass through the applicable drill guide.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Zimmer sent an "URGENT MEDICAL DEVICE RECALL LETTER" dated April 19, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
Quantity in commerce: 69 units
Distribution: Nationwide Distribution.
Product codes and lots: Part No. 00-5887-052-00; lots 62181290 and 62183430

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1376-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1376-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-24

Product code HTW

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)