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Terminated

Lase DiscectomLase Discectomy Device Kit, Models 1100-002 and 1100-002 SHORTy Device Kit, Models 1100-002

FDA Recall Z-2405-2021 · Posted None

Recalling FirmClarus Medical, Llc
Recall StatusTerminated
Product CodeGEX
Date Initiated2021-07-27
Date Terminated2022-09-15
Product Quantity858 units

Reason for Recall

The sterile barrier seal may be compromised.

Firm Action

The affected Domestic customers, Domestic/International Distributors will be notified with a Field Safety Notice. Domestic/International distributors will also include a request for a list of the Distributor s customers.

Root Cause

Packaging process control

Distribution Pattern

Distribution in US - 18 accounts 1 foreign account

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K040424LASER ENDOSCOPIC DECOMPRESSION KIT, MODEL 1100, AND PERCUTANEOUS DISCECTOMY KIT, MODEL 1120Clarus Medical, LLC · 2004-05-11K922881CLARUS MODELS 1100, 1101, 1102, 1103 LASER DISCClarus Medical Systems, Inc. · 1992-11-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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