Global medical device company, Exactech, has issued a recall for knee and ankle replacement implants. The recall has affected at least 250,000 individuals.
According to Drugwatch, the Florida-based company, which has been manufacturing implants such as joint replacements since 1985, issued the recall due to potential degradation of the polyethylene liner in ankle and knee joints caused by improper packaging.
The Polythylene liner is used as new cartilage in knee replacements, ankle replacements and hip replacements. The defective packaging causes early degradation of the medical device, resulting in corrective surgery due to implant failure.
Exactech failed to package implants correctly, using only one oxygen-proof layer instead of the required two-layer protection. Medical replacement implants can be weakened by oxygen, which is why it is recommended to use two-layers of protective packaging. Exactech’s failure to do so resulted in the corrosion of the plastic inserts which weakened the devices.
The company reported the issue to the U.S. Food & Drug Administration in June 2021. According to the report, the recall was due to potential premature wear of some implant configurations and surgical implant positioning.
According to the Legal Examiner, the first recall was issued in August 2021 and applied to some knee and ankle implants. The second recall issued in February 2022 was for all models for knee and ankle replacements made on or after 2004.
The law firm of CaseyGerry is investigating this case and urges those affected by the recall to contact our attorneys at (619) 238-1811 for a confidential case review.