Nextremity Solutions

FDA recalling firm · 7 enforcement events · 15 product records · 2019–2022 · IN

Nextremity Solutions has 7 FDA enforcement events on this register (15 product records) between 2019 and 2022: 7 device; the busiest year was 2019 with 3.

0% of its events are Class I; the most common class is Class II (7). 0 events are listed as ongoing; the recalling firm's address is in IN.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
10 Feb 2022	Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532K Orthopedic surgical instrument	Device	Class II	5	Terminated
13 Jan 2022	Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes SKU: CH-MINI-KT	Device	Class II	2	Terminated
26 Mar 2021	InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Usage: Intended as a three-part construct intended for internal fixation for First Metatarsocuneiform arthrodesis.	Device	Class II	2	Terminated
12 Feb 2020	Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile. REF: NX-4532K - Product Usage: The Nextra Hammertoe Correction System is a system of implants and associated instruments which is indicated for small bone reconstruction limited to inter-digital repair and fusion of the lesser toes.	Device	Class II	1	Terminated
16 Dec 2019	Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. The product is part of the Stratum Foot Plating System, a plate and screws construction indicated for bone fixation.	Device	Class II	1	Terminated
11 Nov 2019	Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST	Device	Class II	3	Terminated
9 Oct 2019	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…	Device	Class II	1	Terminated

By type and class

Device7

Class II7

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Nextremity Solutions by year initiated.

Questions and answers

How many FDA recalls has Nextremity Solutions had?

7 enforcement events (15 product records) on this register, 2019–2022: 7 device.

Are any Nextremity Solutions recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Nextremity Solutions recalls?

7 Class II. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.