Food, drugs, devices › Nextremity Solutions
Device recall: Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST
Nextremity Solutions (Warsaw, IN) initiated this device recall on 11 Nov 2019; FDA lists 3 product records under event 84405, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 10 Sep 2020. Initiation: voluntary: firm initiated. Nextremity Solutions has 7 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Nextremity Solutions, Warsaw, IN.
Reason for recall
"Components 2mm shorter than indicated on the package label"
Distribution
"Nationwide"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0776-2020 | Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST | 87 units | Class II | Terminated | 15 Jan 2020 |
| Z-0777-2020 | Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST | 86 units | Class II | Terminated | 15 Jan 2020 |
| Z-0778-2020 | Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST | 86 units | Class II | Terminated | 15 Jan 2020 |
Context
Other enforcement events for Nextremity Solutions
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 10 Feb 2022 | Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument | Device | Class II | 5 |
| 13 Jan 2022 | Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repa | Device | Class II | 2 |
| 26 Mar 2021 | InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct int | Device | Class II | 2 |
| 12 Feb 2020 | Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra | Device | Class II | 1 |
| 16 Dec 2019 | Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Pla | Device | Class II | 1 |
| 9 Oct 2019 | Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number: STRM-NL-3550ST - Product Usage: The Stratu | Device | Class II | 1 |
All 7 events for Nextremity Solutions
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Components 2mm shorter than indicated on the package label"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Nationwide"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 10 Sep 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.