Short Monobloc Stem Broaches — Class II medical device recall Z-2618-2026
Ongoing recall by Medacta Usa Inc, reported 2026-07-08, distributed nationwide. Surgical instruments used during shoulder arthroplasty procedures does not progressively translate to replicat
| Recall number | Z-2618-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medacta Usa Inc, Memphis, TN, United States |
| Recall initiated | 2026-04-30 |
| Classified | 2026-06-29 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 50 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 07630542768910, 07630542768927, 07630542768934, 07630542768941, 07630542768958, 07630542768965, 07630542768972, 07630542768989, 07630542768996, 07630542769009 |
| Lot numbers | 0970/07630542768910/2585086, 0971/07630542768927/2585087, 0972/07630542768934/2585088, 0973/07630542768941/2585089, 0974/07630542768958/2585090, 0975/07630542768965/2585091, 0976/07630542768972/2585092, 0977/07630542768989/2585093, 0978/07630542768996/2585094, 0979/07630542769009/2585095 |
| Model numbers | 10.0970, 10.0971, 10.0972, 10.0973, 10.0974, 10.0975, 13/04.01.10.0976, 14/04.01.10.0977, 15/04.01.10.0978, 16/04.01.10.0979 |
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
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2618-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.