Recalls / —

—#170307

Product

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

FDA product code

LXH — Orthopedic Manual Surgical Instrument

Device class

Class 1

Medical specialty

Orthopedic

510(k) numbers

K123598

Affected lot / code info

Lot Numbers: C63165, C63306, C63495

Why it was recalled

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

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

NY, TN, Germany, Italy, Great Britain, Singapore

Timeline

Recall initiated

2019-01-07

Terminated

2020-09-17

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #170307. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.