Z-0076-2012

MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX...

Name: Z-0076-2012 MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX...
Creator: Biomet, Inc.
Published: 2011-09-16
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2011-09-16 / Terminated / root cause: manufacturing process

FDA source

Biomet, Inc. began a recall of MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. This device is used to mark... on 2011-09-16. The reason FDA records is "Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. The above lots, as...". 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-0076-2012
Status: Terminated
Initiated: 2011-09-16
Posted: 2011-10-20
Terminated: 2013-03-07
Recalling firm: Zimmer GmbH
Product: MICROPLASTY TAPERLOC 7.5 MM RESECTION GUIDE, STAINLESS STEEL, BIOMET ORTHOPEDICS 56 EAST BELL DRIVE PO BOX 587 WARSAW IN 46582 USA. This device is used to mark the femoral neck resection level
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Biomet has initiated this action following an investigation which identified that the blueprint calls for engraved measurements on both sides on the Microplasty Taperloc 7.5MM Resection Guide. The above lots, as supplied to Biomet by a vendor, are engraved on only one side. To date, Biomet has received 2 reports involving 2 units where the instrument was missing the engraving on one side.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Biomet sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated September 16, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to locate and discontinue use of the affected product. Arrangements will be made for customers to return the affected product to Biomet. To confirm receipt of this notice call Biomet at 800-348-9500 ext. 3755 or 3756. Questions related to this notice should be directed to 574-371-3755 or 3756, Monday through Friday, 8 AM to 5 PM.
Quantity in commerce: 22
Distribution: Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.
Product codes and lots: Part 31-555597, lot numbers: 476500, 572420, 663220, 812350, & 472890.

Product code FZX

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