Recall Z-2050-2014— Zimmer, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer, Inc., initiated 2014-06-25, terminated 2014-10-30. It names 2 FDA 510(k) clearances: K101880, K101977. Product: Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006. Reason: Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial..
- Recalling firm
- Zimmer, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-06-25
- Terminated
- 2014-10-30
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
2 on FDA's record- K101880 — TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
- K101977 — TAPERED SCREW-VENT T IMPLANT
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Zimmer Dental Tapered Screw-Vent Implant, Catalog TSVT6B13, Lot 62284006
Reason for recall
Zimmer Dental is conducting a voluntary recall of a single lot of the Tapered Screw-Vent Implant, Catalog Number TSVT6B13, Lot number 62284006, due to a potential crack in the cap of the outer vial.
Data sourced from openFDA. This site is unofficial and independent of the FDA.