Recalls / —

—#159544

Product

Radial Osteotome Blade, REF 71369314. Used for cutting or preparing bone.

FDA product code

MDM — Instrument, Manual, Surgical, General Use

Device class

Class 1

Medical specialty

General, Plastic Surgery

Affected lot / code info

Lot Numbers: 14HSY0006R, 15MSY0005R, 15KSY0023R, 09FSY0003R, and 12HSY0040R.

Why it was recalled

The expiration date provided on the label is incorrect.

Root cause (FDA determination)

Process change control

Action the firm took

The firm initiated their recall by an Urgent Medical Device Recall Notice on 10/23/2017. The letter identified the affected device and the reason for the recall, as well as the potential risk. The firm instructed users to please inspect their inventory and locate any unused devices from the list of product and batch numbers provided in the Notice. Affected devices must be quarantined immediately. Distributors, must notify their customers of the field action and ensure that the actions are carried out. The attached form should be completed and returned. Questions or concerns can be directed to FieldActions@smith-nephew.com.

Recalling firm

Firm

Smith & Nephew, Inc.

Address

1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

Distribution pattern

Worldwide Distribution -- US, to the states of TN and NJ; and, Australia.

Timeline

Recall initiated

2017-10-23

Terminated

2018-08-24

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #159544. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.