Recall Z-2405-2021— Clarus Medical, Llc
Class II · Terminated
Class II FDA medical device recall by Clarus Medical, Llc, initiated 2021-07-27, terminated 2022-09-15. It names 2 FDA 510(k) clearances: K040424, K922881. Product: Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002. Reason: The sterile barrier seal may be compromised..
- Recalling firm
- Clarus Medical, Llc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-07-27
- Terminated
- 2022-09-15
- Firm location
- Minneapolis, MN, United States
510(k) clearances named in this recall
2 on FDA's record- K040424 — LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120
- K922881 — CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISC
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
Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002
Reason for recall
The sterile barrier seal may be compromised.
Data sourced from openFDA. This site is unofficial and independent of the FDA.