Short Monobloc Stem Broaches, Size/REF: 7/04.01.10.0970, 8/04.01.10.0971, 9/04.01.10.0972, 10/04.01.10.0973, 11/04.01.10.0974, 12/04.01.10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 Part of Medacta Shoulder System
FDA Recall Z-2618-2026 · Posted 2026-06-29
Advertisement
Recalling FirmMedacta Usa Inc
Recall StatusOpen, Classified
Product CodePHX
Date Initiated2026-04-30
Product Quantity50
Reason for Recall
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 laterally than intended, which may increase the risk of fracture in the medial region of the proximal humerus.
Firm Action
On 4/30/2026, field safety notices were emailed to customers who were asked to do the following:
No pre-emptive interventions are recommended, however monitoring of the range of motion and stability should be evaluated during patient follow-up visits as per the standard of care.
" Return all units of the lot numbers listed to firm.
" Forward this notice to all people and organizations potentially affected.
Firm Customer Service can be reached at 312-878-2381.
Root Cause
Device Design
Distribution Pattern
US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement