CLASS II ONGOING Device recall · Reported 23 Jan 2019 · FDA Enforcement Report
Suture Anchor, Nano Corkscrew FT recalled by Arthrex
Arthrex is recalling Arthrex Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled, distributed nationwide in the US. The recall was initiated on 19 Nov 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0724-2019
- FDA event ID
- 81819
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Nov 2018
- FDA classified
- 11 Jan 2019
- Reported
- 23 Jan 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Lead & Heavy Metals
- Device type
- Surgical Instruments
Timeline
| 19 Nov 2018 | Recall initiated by company | |
| 11 Jan 2019 | Classified by FDA | +53 days |
| 23 Jan 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potentially lead to anchor breakage during insertion,
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany
Nationwide AlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMarylandMaine
Questions about this recall
Is Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter recalled?
Yes. Arthrex recalled Suture Anchor, Nano Corkscrew FT (consists of an anchor pre-loaded on a handled inserter on 19 Nov 2018. The recall is Class II and its status is Ongoing. Recall number Z-0724-2019.
Why was it recalled?
Potentially lead to anchor breakage during insertion,
Which lots are affected?
Lots #: 10175216, 1075219, 10199557, and 10199558
Where was it sold?
Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV and the countries of Finland and Germany
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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