FDA Medical Device Recalls (openFDA)
ArthroCare Corporation: ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
- Recall number
- Z-1952-2011
- Recalling firm
- ArthroCare Corporation
- Product
- ArthroCare Opus SpeedLock Knotless Fixation Device; Catalog Number: OM-7500.
- Status
- Terminated
- Initiated
- 2010-09-30
- Posted
- 2011-04-12
- Terminated
- 2011-08-01
- Reason
- 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
- 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
- 170 units
- Distribution
- Product was released for distribution in US.
- Lot, serial or model codes
- Lot Numbers: W100166, WI00167, W100168
- 510(k) numbers
- ["K090615"]
- PMA numbers
- not on file
- Product code
- MBI
- Firm FEI
- 3010813691
- Firm city
- Sunnyvale
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28