CLASS II Device recall · Reported 21 Apr 2021 · FDA Enforcement Report
Tibial Opening Wedge Osteotomy Plate, Titanium recalled by Arthrex
Arthrex is recalling Tibial Opening Wedge Osteotomy Plate, Titanium, distributed nationwide in the US. The recall was initiated on 11 Mar 2021 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-1380-2021
- FDA event ID
- 87584
- Recalling firm
- Arthrex, Naples, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Mar 2021
- FDA classified
- 9 Apr 2021
- Reported
- 21 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Hip & Knee Implants
Timeline
| 11 Mar 2021 | Recall initiated by company | |
| 9 Apr 2021 | Classified by FDA | +29 days |
| 21 Apr 2021 | 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
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Product as listed by the FDA
Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm - Product Usage: use in treatment of non-union, mal-union, and fractures of the proximal tibia and distal femur.
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
Questions about this recall
Is Tibial Opening Wedge Osteotomy Plate, Titanium recalled?
Yes. Arthrex recalled Tibial Opening Wedge Osteotomy Plate, Titanium on 11 Mar 2021. The recall is Class II and its status is Terminated. Recall number Z-1380-2021.
Why was it recalled?
It was discovered that five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts.
Which lots are affected?
Part number: AR-13200T-15.0; Lot code:12135408
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of GA, LA, CA, FL, OR, TX and the countries of India, Russia, Kingdom of Bahrain, Italy, Canada, Sweden, Poland, Australia, New Zealand, and Mexico.
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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