Anatomic Shoulder Prosthesis recallZ-0775-2020 · Medacta Usa Inc · initiated Nov 4, 2019
Terminated
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
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.
FDA root cause category: Device Design
What the company is doing
On 11/4/19 all distributors with recalled product were immediately notified of the recall by phone. On 11/5/19, all distributors were further notified of the recall via email and requested to return their product to the Memphis warehouse.
Recall details
- Recall number
- Z-0775-2020
- Status
- Terminated
- Initiated by the company
- Nov 4, 2019
- Recalling firm
- Medacta Usa Inc
- Quantity
- 207 units
- Product code
- KWS
- FDA submissions
- K170910
- Distribution
- US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
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.
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
GTIN 07630040712613 REF # Lot 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.23 184523 04.01.24 184524 04.01.24 184524 04.01.24 184524 04.01.25 184525 04.01.25 184525 04.01.25 184525 04.01.26 184526 04.01.26 184526 04.01.26 184526 04.01.27 184527 04.01.27 184527 04.01.27 184527 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.27 1901138 04.01.28 184528 04.01.28 184528 04.01.28 1901139 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.29 184529 04.01.30 184530 04.01.30 184530 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.31 184531 04.01.32 184532 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.33 184533 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.34 184534 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.35 184535 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.36 184536 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.37 184537 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.38 184538 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.39 184539 04.01.40 184540 04.01.40 184540 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.41 184541 04.01.43 184543 04.01.43 184543 04.01.43 184543 04.01.44 184544 04.01.44 184544 04.01.44 184544 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.45 184545 04.01.46 184546 04.01.46 184546 04.01.46 184546 04.01.47 184547 04.01.47 184547 04.01.48 184548 04.01.48 184548 04.01.49 184549 04.01.49 184549 04.01.50 184550 04.01.50 184550 04.01.52 184552 04.01.53 184553 04.01.53 184553 04.01.53 184553 04.01.54 184554 04.01.54 184554 04.01.54 184554 04.01.55 184555 04.01.55 184555
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Anatomic Shoulder Prosthesis 04.01.0023Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 recall0 reports
Product lines
Other devices under the same FDA submission
28 devices cleared under K170910 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Anatomic Shoulder Prosthesis 04.01.0132Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented6 reports
- Anatomic Shoulder Prosthesis 04.01.0004Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented5 reports
- Anatomic Shoulder Prosthesis 04.01.0024Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0093Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0129Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented4 reports
- Anatomic Shoulder Prosthesis 04.01.0003Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0006Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented1 death3 reports
- Anatomic Shoulder Prosthesis 04.01.0089Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0130Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented3 reports
- Anatomic Shoulder Prosthesis 04.01.0001Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0005Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
- Anatomic Shoulder Prosthesis 04.01.0026Medacta International SA · Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented2 reports
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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