TeDan Surgical Innovations LLC
Complete recall history across all FDA and CPSC categories — 13 total recalls
TeDan Surgical Innovations LLC 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 (13)
FDA medical device enforcement actions by TeDan Surgical Innovations LLC
| Date | Product | Reason | Class |
|---|---|---|---|
| May 15, 2020 | 3COR DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 16 MM, STERILE, 5/BOX - Product Us... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 14 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | PHANTOM CS QUICK START DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usa... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | PHANTOM CS DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intende... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| May 15, 2020 | 3COR DISTRACTION SCREW, 12 MM, STERILE, 5/BOX - Product Usage: intended to be... | Lack of pouch seal. Product is labelled as sterile. | Class II |
| Jul 16, 2019 | Fukushima suction tubes; Fukushima Malleable Tapered Suction, 3 FR, 145 MM; R... | There was incorrect raw material used in the production of the identified lot. | Class II |
| Feb 18, 2019 | DS-0024 QUICK START DISTRACTION SCREW 14MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufact... | Class II |
| Feb 18, 2019 | D-0012 3COR 12MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufact... | Class II |
| Feb 18, 2019 | DS-0022 QUICK START DISTRACTION SCREW 12MM 5/BOX STERILE - Product Usage: The... | The items identified for recall are labeled as sterile. However, the manufact... | Class II |
| Feb 18, 2019 | D-0014 3COR 14MM DISTRACTION SCREWS, 5/BOX, STERILE - Product Usage: The 3COR... | The items identified for recall are labeled as sterile. However, the manufact... | Class II |
| Jun 11, 2012 | Sterile Distraction Screws of 3 different sizes: 12mm, 14mm and 16mm sold un... | This letter is to notify you that several of our sterile screw products are b... | 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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