FDA Medical Device Recalls (openFDA)
Biomet, Inc.: 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
- Recall number
- Z-0076-2012
- Recalling firm
- Biomet, Inc.
- 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
- Status
- Terminated
- Initiated
- 2011-09-16
- Posted
- 2011-10-20
- Terminated
- 2013-03-07
- Reason
- 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
- 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
- 22
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of AL, CA, IN, MI, OK, and VA and countries of Australia and Chile.
- Lot, serial or model codes
- Part 31-555597, lot numbers: 476500, 572420, 663220, 812350, & 472890.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FZX
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28