Stratum recallZ-0534-2020 · Nextremity Solutions · initiated Oct 9, 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
Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may contain the incorrect screw type and length
FDA root cause category: Labeling mix-ups
What the company is doing
Nextremity Solutions issued Urgent Medical Device notification dated 10/09/19, identifying product, reason for recall, health risk and action to take: review inventory , quarantine for product for return and contact your Zimmer Biomet Rep. will remove product from your facility. Complete and return the Medical Device Response Form. Questions contact customer service 574-371-3071, 8 am-5pm, M-F (EST).
Recall details
- Recall number
- Z-0534-2020
- Status
- Terminated
- Initiated by the company
- Oct 9, 2019
- Recalling firm
- Nextremity Solutions
- Quantity
- 49 units
- Product code
- HRS
- FDA submissions
- K182201
- Distribution
- US Nationwide distribution.
Product description
Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratum Foot Plating System is a plate and screws construct indicated for fixation of fractures, osteotomies, nonunions, malunions and fusions of small bones and small bone segments, particularly in osteopenic bone.
Code information (models, lots, serial numbers)
Lot Number: M1151 UDI: 00817701022558
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Stratum STRM-NL-3550STMedartis Inc. · Screw, Fixation, Bone1 recall1 report
Product lines
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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