Recall Z-0730-2019

Smith & Nephew, Inc. · initiated January 7, 2019

Class II Terminated

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

SL PLUS MIA DOUBLE OFFSET ADAPTER RIGHT 60/25MM, S&N 75004613

Codes / lots: Lot Numbers: C63165, C63306, C63495

Reason for recall

The pin that holds the spring mechanism is not properly mounted. The pin could potentially disassemble.

FDA-determined cause: Process control

Action taken

The firm initiated the recall by email and letter on 01/07/2019. The firm requested the return of the product.

Details

Recall number
Z-0730-2019
Initiated
January 7, 2019
Terminated
September 17, 2020
Product code
LXH – Orthopedic Manual Surgical Instrument
Quantity
72 units
Distribution
NY, TN, Germany, Italy, Great Britain, Singapore
Recalling firm
Smith & Nephew, Inc., Memphis, TN

Official FDA recall record