The FDA labeled it a Class I recall, the most serious type of recall issued by the federal watchdog, indicating that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
According to the FDA, a process monitoring failure led to higher than expected amounts of residue left on the devices after the manufacturing process.
The federal watchdog said that “these residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.”
Zimmer has not yet received any complaints related to the issue for any of the lots in distribution, the FDA said. The recall, issued June 8 and posted today, affects 64 lot numbers that are available on the FDA recall notice.
Last month, Zimmer said it was confident in a mid-June closing of its $13.34 billion merger with crosstown rival Biomet. In April, Zimmer extended the deadline for the merger by 3 months, to July 23, to allow more time to mollify the Federal Trade Commission.