Recall Z-1591-2024— Conformis, Inc.
Class II · Ongoing
Class II FDA medical device recall by Conformis, Inc., initiated 2024-03-11. It names 2 FDA 510(k) clearances: K231233, K210191. Product: Identity Imprint PS Tibial Tray Size 4: Lot 540287. Reason: Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack..
- Recalling firm
- Conformis, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-11
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
2 on FDA's record- K231233 — Identity Imprint CR KRS and Identity Imprint PS KRS
- K210191 — Identity Imprint Knee Replacement System
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
Identity Imprint PS Tibial Tray Size 4: Lot 540287
Reason for recall
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Data sourced from openFDA. This site is unofficial and independent of the FDA.