CLASS II Device recall · Reported 15 Jan 2020 · FDA Enforcement Report
Medacta Shoulder System Humeral Anatomical Metaphysis recalled
Medacta Usa is recalling Medacta Shoulder System Humeral Anatomical Metaphysis, distributed nationwide in the US. The recall was initiated on 4 Nov 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0775-2020
- FDA event ID
- 84397
- Recalling firm
- Medacta Usa, Memphis, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2019
- FDA classified
- 3 Jan 2020
- Reported
- 15 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Nov 2019 | Recall initiated by company | |
| 3 Jan 2020 | Classified by FDA | +60 days |
| 15 Jan 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
Nationwide ArkansasCaliforniaIdahoIllinoisKentuckyNew JerseyOhioSouth CarolinaTexas
Questions about this recall
Is Medacta Shoulder System Humeral Anatomical Metaphysis recalled?
Yes. Medacta Usa recalled Medacta Shoulder System Humeral Anatomical Metaphysis on 4 Nov 2019. The recall is Class II and its status is Terminated. Recall number Z-0775-2020.
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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