Exactech drilled with a warning letter over implant packaging

The FDA issued a warning letter to Exactech regarding packaging issues with its orthopaedic implants, potentially hastening device degradation. Exactech, a manufacturer of orthopaedic implants, received the warning due to packaging flaws expediting the deterioration of its implants. Sent on Jan. 19, the letter followed the FDA's caution against using Exactech's Equinoxe Shoulder Systems packaged in faulty bags, potentially requiring revision surgery.

The implants lacked a crucial barrier layer in their packaging, exposing them to oxidation and accelerating plastic component degradation. Despite this, Exactech declined a voluntary recall of the affected Equinoxe Shoulder System implants made between 2004 and 2021.

Following a September 2023 inspection of Exactech's Gainesville, Florida, headquarters, the FDA sent a warning letter to Exactech's CEO, Darin Johnson. The inspection revealed the company's inadequate addressing of packaging issues, including a lack of comprehensive evaluation of corrective actions.

Exactech responded in October, promising a retrospective review of complaints and procedural revisions, but the FDA found the adequacy of this response uncertain due to a lack of specific details on corrective action outcomes.