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Terminated

ArthroCare brand OPUS Smartstitch Suture Cartridge, Catalog Number: OM-8071; Product is distributed by ArthroCare Corporation, 680 Vaqueros Ave., Sunnyvale, CA 94085

FDA Recall Z-1186-06 · Posted 2006-06-27

Recalling FirmArthroCare Corporation
Recall StatusTerminated
Product CodeKOG
Date Initiated2006-06-07
Date Terminated2006-11-21

Reason for Recall

Potential loss of product sterility due to breach of pouch seal.

Firm Action

Notification letters were sent to all customers in the United States on June 7, 2006. All letters were sent via overnight delivery.

Root Cause

Packaging process control

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022229SMARTSTITCH SUTURE DEVICE, MODEL OM-8500Opus Medical, Inc. · 2002-09-06

Official Source

View FDA Recall →

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

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