—#92313

Product

BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555 Riverside Dr., Palm Beach Gardens, FL.

FDA product code: DZL — Screw, Fixation, Intraosseous
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K874400
Affected lot / code info: Lots 868517, 865348, and 868515.

Why it was recalled

Biomet 3i, Palm Beach Gardens, FL is recalling their Gold Slotted Retaining Screw 3MM, Model Number GS300. Product is Out Of Specification - product was manufactured with a material not specified for use in this product.

Root cause (FDA determination)

Other

Action the firm took

Each US customer was contacted by telephone using a prepared phone script. Following telephone contact, Biomet 3i performed a follow-up of each call with a faxed letter. International customers were first notified by e-mail then by fax letter. Each customer was instructed to check their respective inventory for the affected product and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory. They were also instructed to return the affected product to Biomet 3i. Questions or concerns are directed to Kelly Taylor at the firm at 561-776-6700.

Recalling firm

Firm: Biomet 3i, LLC
Address: 4555 Riverside Dr, Palm Beach Gardens, Florida 33410-4200

Distribution

Distribution pattern: Product was distributed to 3 distributors, 14 direct consumer/users. Product was distributed in Japan, Spain, Switzerland, Uruguay, Paraguay, Mexico, France, Netherlands, Australia, and in the US in KY, DC, IL, RI, MA, NJ and TX.

Timeline

Recall initiated: 2009-10-06
Posted by FDA: 2010-07-06
Terminated: 2010-08-30
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #92313. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.