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FDA Medical Device Recalls (openFDA)

Smith & Nephew, Inc.: SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

Recall number
Z-0730-2019
Recalling firm
Smith & Nephew, Inc.
Product
SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613
Status
Terminated
Initiated
2019-01-07
Posted
not on file
Terminated
2020-09-17
Reason
The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.
Root cause
Process control
Action
The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product.
Quantity
72 units
Distribution
NY, TN, Germany, Italy, Great Britain, Singapore
Lot, serial or model codes
Lot Numbers: C63165, C63306, C63495
510(k) numbers
["K123598"]
PMA numbers
not on file
Product code
LXH
Firm FEI
1020279
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

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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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