Nextremity Solutions

Complete recall history across all FDA and CPSC categories — 15 total recalls

Nextremity Solutions appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (15)

FDA medical device enforcement actions by Nextremity Solutions

Date Product Reason Class
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficu... Class II
Feb 10, 2022 Nextra Hammertoe Correction System 4.5 Middle 3.2 Proximal Kit SKU: NX-4532... Proximal end of the driver is oversized in varying degrees, making it difficu... Class II
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle 3.2 Proximal Kit SKU: NX-3532... Proximal end of the driver is oversized in varying degrees, making it difficu... Class II
Feb 10, 2022 Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical ... Proximal end of the driver is oversized in varying degrees, making it difficu... Class II
Feb 10, 2022 Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU:... Proximal end of the driver is oversized in varying degrees, making it difficu... Class II
Jan 13, 2022 Nextra Cannulated Hammertoe Standard Instrument Kit-indicated for small bone ... During insertion of the middle phalanx implant into bone, the driver may defo... Class II
Jan 13, 2022 Nextra CH Cannulated Hammertoe Mini Instrument Kit-indicated for small bone r... During insertion of the middle phalanx implant into bone, the driver may defo... Class II
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Right, Part Number: IC-LAP-28R - Product U... Product could potentially contain an undersized inner diameter of the 40mm dr... Class II
Mar 26, 2021 InCore Lapidus Disposable Kit 28mm Left, Part Number: IC-LAP-28L - Product Us... Product could potentially contain an undersized inner diameter of the 40mm dr... Class II
Feb 12, 2020 Nextra Hammertoe Correction System-4.5MM Middle, 3.2MM Proximal, SS, Sterile.... Proximal end of the driver in the affected product may be oversized in varyi... Class II
Dec 16, 2019 Stratum Lapidus Plate - Small Rt, Part No. STRM-LAP-SMR, UDI 00817701025467. ... The product contains a different plate than indicated by the package labeling... Class II
Nov 11, 2019 Stratum MDS Screw 3.5x48mm ST Part Number: STRM-MDS-3548ST Components 2mm shorter than indicated on the package label Class II
Nov 11, 2019 Stratum MDS Screw 3.5x46mm ST Part Number: STRM-MDS-3546ST Components 2mm shorter than indicated on the package label Class II
Nov 11, 2019 Stratum MDS Screw 3.5x50mm ST Part Number: STRM-MDS-3550ST Components 2mm shorter than indicated on the package label Class II
Oct 9, 2019 Stratum Foot Plating System-NL LP Screw 3.5x50mm ST, sterile. Catalog Number... Product labeled as STRM-NL-3550ST, NL LP Screw 3.5x50mm ST, lot M1151 may con... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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