PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 23, 2019 Initiated: December 18, 2018 #Z-0747-2019

Product Description

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.

Reason for Recall

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

Details

Recalling Firm
Ethicon, Inc.
Units Affected
840
Distribution
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.
Location
Somerville, NJ

Frequently Asked Questions

What product 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.. Recalled by Ethicon, Inc.. Units affected: 840.
Why was this product recalled?
The sutures inside the packaging are not the same size or type as indicated on the label.
Which agency issued this recall?
This recall was issued by the FDA Devices on January 23, 2019. Severity: Moderate. Recall number: Z-0747-2019.