Stanmore Implants Worldwide Ltd.
Complete recall history across all FDA and CPSC categories — 8 total recalls
Stanmore Implants Worldwide Ltd. 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 (8)
FDA medical device enforcement actions by Stanmore Implants Worldwide Ltd.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 4, 2017 | JTS External Drive Unit JTS Distal Femoral Extendible Implant Femur is int... | Three (3) complaints were identified in which the potential for utilization ... | Class II |
| Dec 7, 2016 | Tibial Component Metal Cased Small Long; Tibial Component Metal Cased Small S... | The recalling firm has received 5 customer inquiries reporting that at least ... | Class II |
| Dec 7, 2016 | Femoral Shaft L=120mm; Femoral Shaft L=135mm; Femoral Shaft L=150mm The prod... | The recalling firm has received 5 customer inquiries reporting that at least ... | Class II |
| Dec 7, 2016 | DF Coated Integral Shaft & Stem 15x30x38; DF Coated Integral Shaft & Stem ... | The recalling firm has received 5 customer inquiries reporting that at least ... | Class II |
| Dec 7, 2016 | Femoral Integral Shaft & Stem 15x27 HA Coated; Femoral Integral Shaft & Ste... | The recalling firm has received 5 customer inquiries reporting that at least ... | Class II |
| Dec 7, 2016 | Tibial Component Fixed Hinge Small Long; Tibial Component Fixed Hinge Small S... | The recalling firm has received 5 customer inquiries reporting that at least ... | Class II |
| May 31, 2016 | METS SMILES Total Knee Replacement | The manufacturer has identified that the stated Femoral Plateau Plates may no... | Class II |
| Apr 12, 2016 | Distal Femoral Replacement (patient specific, custom made orthopedic implant ... | Incorrect component used to manufacture distal femoral replacement. | 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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