The FDA has posted 19 enforcement recalls of reverse configuration shoulder prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Jul 8, 2026.
Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicate implant geometry, so the reaming guide and the stem reamer are positioned approximately 0.2 mm per size more…
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
Knee and Humeral socket implants contain incorrect labeling.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Shoulder Prosthesis, Reverse Configuration”). Informational only — verify against the FDA before acting.