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REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING… recallZ-2873-2011 · Biomet Microfixation, Inc. · initiated May 17, 2010

Terminated All recalls posted in July 2011

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, Inc. 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 May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.

FDA root cause category: Labeling mix-ups

What the company is doing

Biomet Microfixation notified distributors and customers by letter, email and telephone calls. Distributors and customers were instructed to fill out and return the Inventory Reconciliation sheet, via Fax to 904-741-9425. Distributors were also instructed to notify their customers if the product was distributed further. For questions regarding this recall customers were instructed to call 1-800-874-7711 or 904-741-4400, ext. 468.

Recall details

Recall number
Z-2873-2011
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 17, 2010
Posted by the FDA
Jul 22, 2011
Recalling firm
Biomet Microfixation, Inc.
Quantity
927
Product code
HWC
FDA submissions
K953385
Distribution
Worldwide Distribution - USA including AL, CA, GA, HI, IL, MO, NC, NY, TX and the country of Japan.

Product description

"***REF: 91-6704***THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM (.059X.159") (WXL)***TITANIUM***NON-STERILE PRODUCT***BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA*** www.biometmicrofixation.com***QTY 00001***". Internal fixation screws intended to aid in the alignment and stabilization of bone in the oral cranio-maxillofacial skeletal system.

Code information (models, lots, serial numbers)

Lot 173770

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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