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Terminated

Tapered Screw-Vent MTX Model TSVTB11

FDA Recall Z-0284-2018 · Posted None

Recalling FirmZimmer Dental Inc
Recall StatusTerminated
Product CodeDZE
Date Initiated2017-11-20
Date Terminated2024-02-28
Product Quantity500 units

Reason for Recall

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

Firm Action

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.

Root Cause

Under Investigation by firm

Distribution Pattern

US, Canada, France, Italy, Spain, Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101977TAPERED SCREW-VENT T IMPLANTZimmer Dental, Inc. · 2010-09-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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