ArticleCureus2018
An Analysis of Foot and Ankle Device Recalls by the Food and Drug Administration.
Article in Cureus, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Biomechanically superior treatments do not translate into improved outcomes in randomized controlled trials.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2022Pooled it
- Recall Rates of Total Knee Arthroplasty Devices Are Dependent on the FDA Approval Process.Cureus · 2020Article
- Impact of Design on Medical Device Safety.Therapeutic innovation & regulatory science · 2020Review
- Evaluating the efficacy of bronchoscopy for the diagnosis of early stage lung cancer.Journal of thoracic disease · 2020Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Introduction Orthopaedic devices represent 12% of all medical device recalls. Products are approved through pre-market approval (PMA) or the 510(k) premarket notification process. No previous evaluation was found in the literature evaluating foot and ankle device recalls. The field of foot and ankle subspecialty has seen a rapid growth in innovation related to implants in recent years. Methods The Food and Drug Administration (FDA) Device Recall database was evaluated for all foot and ankle devices from 2007 through 2017 for the manufacturer, process of approval, type of implant, recall class, dates of initiation and termination of the recall, manufacturer determined reason, quantity affected, and distribution within the United States or internationally. Results A total of 161 products from 33 companies were identified with 158 (98.1%) approved through the 510(k) process. The most common reason for device recall was due to the device breaking intraoperatively or postoperatively. The average length of the recall was 487.5 days. Conclusions Device recall is not an uncommon event with the majority of products approved through the less demanding 510(k) process.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.