MSS - Monobloc stem recallZ-2618-2026 · Medacta Usa Inc · initiated Apr 30, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medacta Usa Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2618-2026
- Status
- Open, Classified
- Initiated by the company
- Apr 30, 2026
- Posted by the FDA
- Jun 29, 2026
- Recalling firm
- Medacta Usa Inc
- Quantity
- 50
- Product code
- PHX
- FDA submissions
- K250644
- Distribution
- US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Product description
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
Code information (models, lots, serial numbers)
REF/UDI/Lot: 04.01.10.0970/07630542768910/2585086, 04.01.10.0971/07630542768927/2585087, 04.01.10.0972/07630542768934/2585088, 04.01.10.0973/07630542768941/2585089, 04.01.10.0974/07630542768958/2585090, 04.01.10.0975/07630542768965/2585091, 04.01.10.0976/07630542768972/2585092, 04.01.10.0977/07630542768989/2585093, 04.01.10.0978/07630542768996/2585094, 04.01.10.0979/07630542769009/2585095
Devices named in this recall
10 devices in the FDA device registry whose identifier appears in the recall's code information.
- MSS - Monobloc stem 04.01.10.0970Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0971Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0972Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0973Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0974Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0975Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0976Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0977Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0978Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
- MSS - Monobloc stem 04.01.10.0979Medacta International SA · Orthopedic manual surgical instrument1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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