Recall Z-0724-2019— Arthrex, Inc.
Class II · Ongoing
Class II FDA medical device recall by Arthrex, Inc., initiated 2018-11-19. It names one FDA 510(k) clearance: K180118. Product: Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist. Reason: Potentially lead to anchor breakage during insertion,.
- Recalling firm
- Arthrex, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2018-11-19
- Firm location
- Naples, FL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter including suture, with needles.) Part Number AR-1317FT Product Usage: Soft tissue fixation to bone in the hand and wrist
Reason for recall
Potentially lead to anchor breakage during insertion,
Data sourced from openFDA. This site is unofficial and independent of the FDA.