Medacta Shoulder Implant Recall Due to Screw Insertion Limitation
Medacta USA Inc. is recalling specific lots of Humeral Anatomical Cementless Metaphysis implants because a dimensional condition may limit the insertion of the locking screw.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a functional defect that could limit the secure locking of the implant, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Medacta USA Inc. is recalling 207 units of the Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, reference numbers 04.01.0023 through 04.01.0055, in all sizes. The recall covers specific lot numbers distributed nationwide in Kentucky, New Jersey, Illinois, South Carolina, California, Texas, Idaho, Arkansas, and Ohio.
The recall was initiated because certain lot numbers have a dimensional condition that could limit the insertion of the screw used to lock the metaphysis to the humeral diaphysis. The Medacta Anatomic Shoulder Prosthesis is indicated for the 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.
Healthcare providers and patients who have received these specific implants should contact Medacta USA Inc. or their healthcare provider for instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- 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…
- Manufacturer
- Medacta Usa Inc
- Affected units
- 207
Distribution
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