Ossur Americas

Complete recall history across all FDA and CPSC categories — 12 total recalls

Ossur Americas 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 (12)

FDA medical device enforcement actions by Ossur Americas

Date Product Reason Class
Aug 29, 2022 OSSUR Power Knee REF PKA10003 OSSUR Power Knee REF PKA10003 OSSUR Power... Battery may dislodge from the Power Knee Class II
May 30, 2022 OSSUR VARIFLEX SUBA JUNIOR foot and ankle external prosthesis, sized for chil... Due to receiving complaints related to broken (cracked) prosthetic foot with ... Class II
Nov 9, 2021 Miami J Select Collar, Item: MJS-101, and Miami J Select Collar Set, Item: MJ... Instructions for use were updated to include additional information to facili... Class II
Jun 1, 2021 OSSUR MIAMI J SELECT COLLAR - Product Usage: is intended to provide gross imm... Due to insufficient column strength of the racks for all load conditions, rac... Class II
Jun 21, 2018 Ossur, LIL Angel Vest, Part/ Description: 545100K/ LIL ANGEL VEST P2 KOD... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur, Sterile, Part/ Description: 505300T/ CB RING KIT TI SM; 505300V2... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur, J Tong, Sterile, Part/ Description: JT-115/ J TONG MED/LGE-No App... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur Skull Pin, Sterile Ceramic Tip Pin, Part/ Description: 516CS/ Skul... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur OB Resolve, Sterile, Part/ Description: 505300D/ OB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur CB Resolve, Sterile, Part/ Description: 505300C/ CB RESOLVE STERIL... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur, ReSolve Halo Vest, Part/ Description: 545700K/ ReSolve Halo Vest-... Halo system products labeled MR conditional will undergo confirmatory safety ... Class II
Jun 21, 2018 Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pi... Halo system products labeled MR conditional will undergo confirmatory safety ... 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.

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