Device recall

Z-0153-2015: Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline…

FDA device recall · Class II · Zimmer Dental Inc

Key facts

Recall number (Z-number) Z-0153-2015
Recall event 69392
Product Spline Twist Implant, HA 3.25mmD X 15mmL; Part No. 2135. Zimmer Dental Spline implant systems are designed for use in edentulous mandibles or maxillae for attachment of complete denture prostheses for immediate or conventional loading, or as a terminal or intermediary abutment for fixed or removable…
Product code DZE
Recalling firm Zimmer Dental Inc
Recall class Class II
Status Terminated
Termination date Apr 28, 2015
510(k) numbers K093164
FEI number 1038806

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 100–999 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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