BIOMET 3i GS300 GOLD SLOTTED SCREW-3mm, STERILE, Rx Only. Made in USA. Lots 868517, 865348, and 868515. BIOMET 3i, 4555
FDA device recall Z-1956-2010 · posted 2010-07-06 · Terminated
Recall details
- Recalling firm
- Biomet 3i, LLC
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- DZL
- Quantity affected
- 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 K
- Date initiated
- 2009-10-06
- Date posted
- 2010-07-06
- Date terminated
- 2010-08-30
- Location
- Palm Beach Gardens, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NON-ROTATING GOLD CYLINDER AND SCREW (K874400) | Implant Innovations International, Inc. | 1988-03-02 |