Stratum recallZ-0776-2020 · Nextremity Solutions · initiated Nov 11, 2019
Terminated
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 Nextremity Solutions 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
Components 2mm shorter than indicated on the package label
FDA root cause category: Packaging process control
What the company is doing
Nextremity Solutions issued Urgent Medical Device Recall letter on 11/11/19 stating reason for recall, health risk and action to take: do not use, quarantine and return to Zimmer Biomet representative who will remove product, Contact customer service at 574-371-3071 between 8am -5pm(EST) M-F.
Recall details
- Recall number
- Z-0776-2020
- Status
- Terminated
- Initiated by the company
- Nov 11, 2019
- Recalling firm
- Nextremity Solutions
- Quantity
- 87 units
- Product code
- HWC
- FDA submissions
- K182201
- Distribution
- Nationwide
Product description
Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Code information (models, lots, serial numbers)
Lot Number: M1266 UDI: 00817701023159
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Stratum STRM-MDS-3546STMedartis Inc. · Screw, Fixation, Bone1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 84405).
- Z-0777-2020 · TerminatedStratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST
- Z-0778-2020 · TerminatedStratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST
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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