CLASS II Device recall · Reported 17 May 2017 · FDA Enforcement Report
Anthrex PEEK SwiveLock SP Vented, Self-Punching recalled by Arthrex
Arthrex is recalling Anthrex PEEK SwiveLock SP Vented, Self-Punching, distributed in 48 states. The recall was initiated on 24 Mar 2017 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-2044-2017
- FDA event ID
- 76986
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Mar 2017
- FDA classified
- 5 May 2017
- Reported
- 17 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 24 Mar 2017 | Recall initiated by company | |
| 5 May 2017 | Classified by FDA | +42 days |
| 17 May 2017 | 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
Some eyelets broke from SwiveLock Anchor on insertion.
Product as listed by the FDA
Anthrex PEEK SwiveLock SP Vented, 4.75 mm x 24.5 mm, Self-Punching
Where it was distributed
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusettsMaryland
Questions about this recall
Is Anthrex PEEK SwiveLock SP Vented, Self-Punching recalled?
Yes. Arthrex recalled Anthrex PEEK SwiveLock SP Vented, Self-Punching on 24 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-2044-2017.
Why was it recalled?
Some eyelets broke from SwiveLock Anchor on insertion.
Which lots are affected?
Unique Device Identifier: 00888867026926 Batch Number: 10072597 - Expiration Date 10/31/2021
Where was it sold?
AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico Australia, Austria, Bolivia, Canada, Estonia, Germany, Guam, India, Ireland, Israel, Portugal, South Africa, Switzerland, Uruguay and (Japan - DOD)
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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