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Product is labeled in part: "***REF: 01-7036, LOT 999999… recallZ-1286-2012 · Biomet Microfixation, LLC · initiated Apr 26, 2010

Terminated All recalls posted in March 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Biomet Microfixation, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Error in labeling

What the company is doing

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.

Recall details

Recall number
Z-1286-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Apr 26, 2010
Posted by the FDA
Mar 23, 2012
Recalling firm
Biomet Microfixation, LLC
Quantity
23
Product code
JEY
FDA submissions
K953385
Distribution
USA Nationwide Distribution including the states of: California and Texas.

Product description

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.

Code information (models, lots, serial numbers)

Lot 193690

Other devices under the same FDA submission

41 devices cleared under K953385 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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