The FDA has posted 8 enforcement recalls of reverse configuration shoulder prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Aug 26, 2026.
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
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.
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.