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
FDA device recall Z-2618-2026 · posted 2026-06-29 · Open, Classified
Recall details
- Recalling firm
- Medacta Usa Inc
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- PHX
- Quantity affected
- 50
- Distribution
- US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
- Date initiated
- 2026-04-30
- Date posted
- 2026-06-29
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MSS - Monobloc stem (K250644) | Medacta International S.A. | 2026-02-03 |