Z-1286-2012

Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100...

Name: Z-1286-2012 Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100...
Creator: Biomet Microfixation, LLC
Published: 2010-04-26
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2010-04-26 / Terminated / root cause: labeling and UDI

FDA source

Biomet Microfixation, LLC began a recall of Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE... on 2010-04-26. The reason FDA records is "On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly". 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-1286-2012
Status: Terminated
Initiated: 2010-04-26
Posted: 2012-03-23
Terminated: 2012-04-18
Recalling firm: Biomet Microfixation
Product: Product is labeled in part: "***REF: 01-7036, LOT 999999, "1.5MM" SYSTEM PLATE L-SHAPE, 3 X 3 HOLE, 100 DEGREE, QTY 00001, CE 0086, 2010-04 *** NON-STERILE PRODUCT ***, LEFT, X-LONG, 0.6 MM TITANIUM, BIOMET MICROFIXATION, 1540 TRADEPORT DRIVE, JACKSONVILLE, FL 32218 USA, 01-736, LOT 999999, QTY 00001, L-SHAPE, 3 X 3 HOLE, 100 DEGREE, LEFT, X-LONG, 0.6 MM, CE 0086.***" Product Usage - CTS Usage: Bone-plate - internal fixation devices intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.
Product code: JEY Plate, Bone
Reason for recall: On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: Biomet Microfixation, LLC sent an Urgent Medical Device Safety Alert letter dated April 21, 2010 to all consignees affected. Each consignee was notified by E-mail, letter or telephone call the week of April 26, 2010. The letter identified the affected product, problem and actions to be taken. Consignees were instructed to fill out the attached Inventory Reconciliation sheet and FAX it to the attention of the Global Complaint Coordinator at 904-741-9425. If the affected product have been further distribute, consignees are instructed to notify the recipient of this action by providing the recipient a copy of this notice. This letter must be given to the personnel responsible for receiving field action notices. For questions contact Christy Cain at 1-800-874-7711 or 904-741-4400, extension 468, Monday through Friday, 8am-4pm ET.
Quantity in commerce: 23
Distribution: USA Nationwide Distribution including the states of: California and Texas.
Product codes and lots: Lot 193690

Product code JEY

K953385Class IILorenz 1.0Mm, 1.5Mm, 2.0Mm SystemWalter Lorenz Surgical, Inc. / cleared 1995-09-28

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)