Straumann Manufacturing, Inc.
Complete recall history across all FDA and CPSC categories — 11 total recalls
Straumann Manufacturing, Inc. 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 (11)
FDA medical device enforcement actions by Straumann Manufacturing, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Oct 2, 2018 | Neodent¿ GM Mini Conical Abutment - Product Usage: Mini Conical Abutments are... | Laser engraved label does not match with the item in the package | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 0.15 ml 5-Pack. Enamel Matrix Derivative. Article Number ... | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 0.7 ml Multipack USA. Enamel Matrix Derivative. Article N... | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 0.3 ml Multipack. Enamel Matrix Derivative. Article Numbe... | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 0.3 ml Multipack USA. Enamel Matrix Derivative. Article N... | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 0.7 ml Multipack. Enamel Matrix Derivative. Article Numbe... | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Mar 23, 2018 | Straumann¿ Emdogain 015, USA. Enamel Matrix Derivative. Article Number 075.099 | A change regarding the shelf life of a raw material was implemented without a... | Class II |
| Nov 23, 2016 | Straumann Twist Drill PRO ¿4.2mm,long,41mm,SS-Non sterile. Dental implant ac... | Drills cannot be inserted into handpiece due to tolerance specification not met | Class II |
| Nov 23, 2016 | Straumann Drill 1, short, ¿ 2.2mm, l 33.0mm, SS-Non sterile. Dental implant ... | Drills cannot be inserted into handpiece due to tolerance specification not met | Class II |
| Jul 14, 2016 | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA 10mm, TiZr, NTP Article Number... | Misalignment with the Loxim transfer piece markings, the positioning of the i... | Class II |
| Jul 14, 2016 | Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Numbe... | Misalignment with the Loxim transfer piece markings, the positioning of the i... | 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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