FDA Medical Device Recalls (openFDA)
Medacta Usa Inc: 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.
- Recall number
- Z-0775-2020
- Recalling firm
- Medacta Usa Inc
- 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.
- Status
- Terminated
- Initiated
- 2019-11-04
- Posted
- not on file
- Terminated
- 2021-05-21
- 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.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 207 units
- Distribution
- US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K170910"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- 3006639916
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28