Recall Z-1956-2010 ยท DZL Screw, Fixation, Intraosseous
Biomet 3i, LLC
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.
| Date | Jul 6, 2010 (initiated Oct 6, 2009) |
| Status | Terminated |
| Reason | 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 | Other |
| Action | 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 a |
| Quantity | 495 screws |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K874400 | NON-ROTATING GOLD CYLINDER AND SCREW Implant Innovations International, Inc., Mar 2, 1988 |