Device recall
Z-2695-2016: ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20…
FDA device recall · Class I · MicroPort Orthopedics Inc.
Key facts
| Recall number (Z-number) | Z-2695-2016 |
|---|---|
| Recall event | 74785 |
| Product | ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are… |
| Product code | MBH |
| Recalling firm | MicroPort Orthopedics Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 26, 2017 |
| 510(k) numbers | K061223 |
| FEI number | 3010536692 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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