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Terminated

Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only

FDA Recall Z-0652-2014 · Posted 2014-01-09

Recalling FirmArthroCare Medical Corporation
Recall StatusTerminated
Product CodeLXH
Date Initiated2013-12-09
Date Terminated2015-04-08
Product Quantity76

Reason for Recall

A sharp edge on the cannulated tip of the device may damage or cut a suture.

Firm Action

All consignees were provided with written notice via Urgent Recall Notification dated December 9, 2013 with delivery confirmation. In addition, the firm plans on notifying the EU, and the governments of France, Germany, Switzerland, and Spain. The firm will also notify the Swedish government because the firm's EU representative is located in Sweden.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide distribution: US (nationwide) including states of: CA, FL, GA, IL, IN, KY, MN, MO, NY, OH, TX, and WI. Internationally to: Canada, France, Germany, Spain, and Switzerland.

Official Source

View FDA Recall →

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

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