Recall Z-0775-2020— Medacta Usa Inc
Class II · Terminated
Class II FDA medical device recall by Medacta Usa Inc, initiated 2019-11-04, terminated 2021-05-21. It names one FDA 510(k) clearance: K170910. Product: Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.. Reason: Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis..
- Recalling firm
- Medacta Usa Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-04
- Terminated
- 2021-05-21
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.
Reason for recall
Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.
Data sourced from openFDA. This site is unofficial and independent of the FDA.