Z-2618-2026Class II

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...

Name: Z-2618-2026 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...
Creator: Medacta Usa Inc
Published: 2026-04-30
License: https://open.fda.gov/license/

Medacta USA, Inc. / initiated 2026-04-30 / Open, Classified / root cause: design

FDA source

Medacta Usa Inc began a recall of 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... on 2026-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2618-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-04-30
Posted: 2026-06-29
Recalling firm: Medacta USA, Inc.
Product: 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
Product code: PHX Shoulder Prosthesis, Reverse Configuration
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 50
Distribution: US Nationwide distribution in the states of CO, AR, IN, PA, UT, FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2618-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2618-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-07-08	2026-06-29

Product code PHX

K250644Class IIMSS - Monobloc stemMedacta International S.A. / cleared 2026-02-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)