Z-0108-2011

2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot...

Name: Z-0108-2011 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot...
Creator: Biomet Microfixation, Inc.
Published: 2010-08-31
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-08-31 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, Inc. began a recall of 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT... on 2010-08-31. The reason FDA records is "Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate)". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0108-2011
Status: Terminated
Initiated: 2010-08-31
Posted: 2010-10-20
Terminated: 2010-11-19
Recalling firm: Biomet Microfixation
Product: 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150. Product labeling reads: (1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG. (2.) QTY 00001, CE 0086, *** NON-STERILE PRODUCT***, 1.0 MM TITANIUM, BIOMET MICROFIXATION, 1520 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, www.biometmicrofixation.com. (3.) #01-9205, LOT 999999, QTY 00001, 4 HOLE PLATE, STRAIGHT, LONG, 1.0 MM, CE 0086
Product code: JEY Plate, Bone
Reason for recall: Mislabeled size: The 2.0/1.0 4 hole long plate, Lot 120150 is labeled as 01-9205 (2.0/1.0 4 Hole Long Plate), however, the package contains a 01-9204 (2.0/1.0 4 Hole Regular Plate).
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Biomet Microfixation sent URGENT MEDICAL DEVICE RECALL NOTICES dated August 31, 2010 to its customers and distributors, identifying the affected product and actions to be taken by customers. Customers were requested to check their inventory for product and return any affected product to Biomet Microfixation. Customer questions or concerns should be directed to Laura Sabo, VP Global QA/RA at 904-741-4500.
Quantity in commerce: 56
Distribution: Worldwide Distribution: USA including states of Hawaii and Kansas, and the countries of Australia, Denmark, Italy, Jordan, and South Africa.
Product codes and lots: Lot 120150.

Product code JEY

K854886Class IIWuerzburg Titanium Mini Bone Plates & Bone ScrewsWalter Lorenz Surgical, Inc. / cleared 1986-01-21

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)