FDA Device

Tapered Screw-Vent MTX Model TSVTB11

Hazard

Some implant vial caps in the recalled implant lot may inadvertently crack as the result of a manufacturing assembly condition.

What You Should Do

Remedy

Recall notification letters will be sent to distributors and clinicians on or about the last week of November 2017. International distributors will be notified via courier or email. Clinicians will be instructed to; 1. Follow any specified patient monitoring instructions, 2. Return Attachment 1 (Acknowledgment of Responsibility) to Zimmer Biomet, 3. Review their inventory and returning any affected product.

Products

Tapered Screw-Vent MTX Model TSVTB11
Brand
Zimmer Dental Inc
UPC
lot,#63519794; UDI: (01)00889024019935 (17)211130 (10)63519794

Units Affected

500 units