Ethicon, Inc. recalls PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* s…

Recall date

December 18, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0747-2019

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

The products were distributed to the following US states: AR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, and WI.

Why it was recalled

The sutures inside the packaging are not the same size or type as indicated on the label.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.