Lower riskMedical device recall · FDA · Published March 11, 2021
Arthrex Tibial Plate Recall: Confused Part Numbers Risk Misuse
Arthrex recalls titanium tibial plates with confused part numbers that could lead to incorrect use in bone treatments. Affected items have specific part and lot codes.
“Arthrex Tibial Plate Recall: Confused Part Numbers Risk Misuse.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63106-arthrex-tibial-plate-recall-confused-part-numbers-risk-misuse. Based on FDA recall #Z-1380-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1380-2021%22&limit=1).
The FDA announced on March 11, 2021, that Arthrex, Inc. voluntarily recalled 32 units of Tibial Opening Wedge Osteotomy Plates due to processing errors. The hazard involves five parts being processed with incorrect part numbers.
How to tell if you have it
Brand: Arthrex
Product: Tibial Opening Wedge Osteotomy Plate, Titanium, 15.0 mm
Part number: AR-13200T-15.0
Lot code: 12135408
The hazard
Five AR-13200ST-15.0 parts were processed as AR-13200T-15.0 parts, according to the FDA recall record Z-1380-2021.
Context
GovInfoNow's records show Arthrex, Inc. has 12 other recalls on record since October 3, 2017. Other recent recalls of similar products include Howmedica Triathlon Baseplate Size 3 Recall (May 19, 2026), Howmedica Triathlon Baseplate Size 4 Recall (May 19, 2026), and Straumann Custom Abutment AS Ti Recall (March 17, 2026).
How to tell if you have this one
Check for part number AR-13200T-15.0 or lot code 12135408 on the plate. The product is used for treating non-union, mal-union, and fractures of the tibia and femur.
Brand
Arthrex
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Part Number
Verify the part number on the plate is AR-13200T-15.0 or AR-13200ST-15.0.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 6 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: California, Florida, Georgia, Louisiana, Oregon, Texas.
Recall timeline
FDA terminated this recall 3.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1380-2021 (March 11, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1380-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.