Z-0652-2014Class II

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

Name: Z-0652-2014 Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Creator: ArthroCare Medical Corporation
Published: 2013-12-09
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2013-12-09 / Terminated / root cause: manufacturing process

FDA source

ArthroCare Medical Corporation began a recall of Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only on 2013-12-09. FDA classified it as Class II and gives the reason as "A sharp edge on the cannulated tip of the device may damage or cut a suture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0652-2014
Classification: Class II
Status: Terminated
Initiated: 2013-12-09
Posted: 2014-01-09
Terminated: 2015-04-08
Recalling firm: ArthroCare Corporation
Product: Arthrocare SPORTS MEDICINE, Knot Pusher, REF 25-3011, LOT #1049402, CON 1, 2013-10, NON-STERILE, Rx only
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: A sharp edge on the cannulated tip of the device may damage or cut a suture.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 76
Distribution: 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.
Product codes and lots: Catalog #25-3011, Lot #1049402

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0652-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0652-2014	Class II	Terminated	Voluntary: Firm initiated	2014-01-15	2014-01-09

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)