Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF… recallZ-2361-2026 · Medartis AG · initiated Apr 24, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medartis AG or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The cannulation of the CCS screw is not centered.
FDA root cause category: Under Investigation by firm
What the company is doing
Medartis issued an URGENT: Field Safety Notice - Recall to its consignees on 5/4/2026 via USPS. The notice explained the problem with the device, potential risks associated with its use, intraoperatively and postoperatively, and provided postoperative patient recommendations. Response to the Field Safety Notice should be made to: [email protected] or Medartis Inc., 1195 Polk Drive Warsaw, IN 46582. The device are to be returned.
Recall details
- Recall number
- Z-2361-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 24, 2026
- Posted by the FDA
- Jun 9, 2026
- Recalling firm
- Medartis AG
- Quantity
- 13 units
- Product code
- HWC
- FDA submissions
- K202589
- Distribution
- US Nationwide distribution in the states of LA, TX. IN, CA, NC.
Product description
Medartis APTUS, 5.0 headedCCS Long Thread 50/20mm, REF A-8216.50/1, 1/Pkg; Cannulated Compression Screws for bone fixation
Code information (models, lots, serial numbers)
UDI/DI 07630037887706, Lot Numbers: 25444702, 24425542, 24404471, 25441997
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- APTUS A-8216.50/1Medartis AG · Screw, fixation, bone1 recall0 reports
Other devices under the same FDA submission
1 device cleared under K202589 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- APTUS A-5886.38/1SMedartis AG · Screw, fixation, bone1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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