Medacta Usa Inc
Complete recall history across all FDA and CPSC categories — 16 total recalls
Medacta Usa 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 (16)
FDA medical device enforcement actions by Medacta Usa Inc
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H16, REF 03.30.303, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H12, REF 03.30.301, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H18, REF 03.30.304, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Mar 8, 2023 | MectaLIF ANTERIOR - Antibackout Lag Cover, REF 03.30.305, interbody fusion de... | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H14, REF 03.30.302, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Mar 8, 2023 | MectaLIF ANTERIOR - Lag Plate Flush H10, REF 03.30.300, interbody fusion device | There is a potential for breakage of the small screw used to affix the anti-b... | Class II |
| Oct 27, 2022 | NextAR Shoulder Surgical Technique, Shoulder NextAR RSA Platform, CT based co... | A warning has been added to the Surgical Technique for NextAR Shoulder, advis... | Class II |
| Apr 13, 2022 | GMK Efficiency - GMK Sphere CR Insert Instrument Set Size 1 | A Size 2 trial baseplate was assembled with Size 1 instrument sets. | Class II |
| Nov 4, 2019 | Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through... | Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis h... | Class II |
| Nov 15, 2017 | Medacta International MiniMAX CEMENTLESS ANATOMICAL STEM, 12/14: for cementle... | Complaint monitoring noted a trend of packaging being breached for the MiniMA... | Class II |
| Oct 24, 2017 | The GMK knee system: designed for cemented use in total knee arthroplasty. S... | Medacta has observed a worldwide occurrence rate of post-operative insert scr... | Class II |
| May 19, 2017 | Medacta GMK HINGE, Tibial Insert Fixed, SIZE 2, HEIGHT 23 mm, REF 02.09.0223H... | One lot of product does not include a screw for attachment to the tibial base... | Class II |
| Dec 7, 2016 | Medacta International SA, M.U.S.T. Rod, REF 03.50.433, Size 5.5mm, Length 480... | Damaged packaging, lack of sterility assurance | Class II |
| Dec 17, 2012 | Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Meda... | The tip of the Quadra Trial Broach size 0, broke during a surgery. | Class II |
| Jan 15, 2010 | Versafitcup Impacting Ring Model Number: 01.26.10.0133 (46mm), 01.26.10.01... | Medacta USA is recalling Versafitcup Impacting Ring because the impaction rin... | Class II |
| Oct 13, 2008 | Quadra S Offset Broach Handle The offset broach handle is intended to atta... | Medacta USA Inc has initiated a recall on the Quadra S Offset Broach Handle 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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