Z-3289-2011

Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral...

Name: Z-3289-2011 Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral...
Creator: Biomet, Inc.
Published: 2011-08-03
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-08-03 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. Instrument that is attached to the... on 2011-08-03. The reason FDA records is "Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed". 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-3289-2011
Status: Terminated
Initiated: 2011-08-03
Posted: 2011-09-30
Terminated: 2011-10-26
Recalling firm: Zimmer GmbH
Product: Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form. For information or questions on this recall call Biomet at (574) 372-1570.
Quantity in commerce: 6 units (internationally)
Distribution: International Distribution Only: Canada, Australia, and Columbia.
Product codes and lots: Part numbers: 406993, Lot numbers:176070 and 657550; and 406993-00, Lot number : 203119.

Product code LXH

K023063Class IIComprehensive Humeral Fracture SystemBiomet Orthopedics, Inc. / cleared 2002-12-13

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)