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FDA Medical Device Recalls (openFDA)

Wright Medical Technology Inc: WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.

Recall number
Z-1924-2020
Recalling firm
Wright Medical Technology Inc
Product
WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Status
Terminated
Initiated
2020-04-09
Posted
not on file
Terminated
2020-11-02
Reason
One lot of INBONE Tibial Trays is missing the plasma coating.
Root cause
Nonconforming Material/Component
Action
The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return.
Quantity
22 units
Distribution
US Nationwide distribution.
Lot, serial or model codes
Lot code 1619947
510(k) numbers
["K051023"]
PMA numbers
not on file
Product code
HSN
Firm FEI
1043534
Firm city
Arlington
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

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