Z-1952-2011

ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500

Name: Z-1952-2011 ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500
Creator: ArthroCare Corporation
Published: 2010-09-30
License: https://open.fda.gov/license/

ArthroCare Corporation / initiated 2010-09-30 / Terminated / root cause: manufacturing process

FDA source

ArthroCare Corporation began a recall of ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500 on 2010-09-30. The reason FDA records is "During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone...". 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-1952-2011
Status: Terminated
Initiated: 2010-09-30
Posted: 2011-04-12
Terminated: 2011-08-01
Recalling firm: ArthroCare Corporation
Product: ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
Product code: MBI Fastener, Fixation, Nondegradable, Soft Tissue
Reason for recall: During surgical procedure the product has the potential for separation of the plug guide. Separation of the plug guide may compromise the ability of the inserter to fully drive the implant completely into the bone, which may also compromise the ability to tension the suture properly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 9/30/2010, Arthrocare notified customers via letters explaining the reason for the recall and requesting the product be returned.
Quantity in commerce: 170 units
Distribution: Product was released for distribution in US.
Product codes and lots: Lot Numbers: W100166, WI00167, W100168

Product code MBI

K090615Class IIOpus Speedlock Knotless Fixation DeviceArthrocare Corp. / cleared 2009-06-03

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)