The FDA has posted 6 enforcement recalls of metal/polymer cemented semi-constrained shoulder prosthesis devices since 2025, none of them Class I (most serious). Most recent report: Apr 15, 2026.
Affected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are incompatible with the Tornier HRS Max system.
Knee and Humeral socket implants contain incorrect labeling.
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery.…
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented”). Informational only — verify against the FDA before acting.