Data Foundry

Medical device recalls 2019

PERMA-HAND Silk Suture Size 5 — Class II medical device recall Z-0747-2019

Terminated recall by Ethicon, Inc., reported 2019-01-23, distributed in AR, CA, FL, GA, KS, LA, MO, MS…. The sutures inside the packaging are not the same size or type as indicated on the label.

Recall numberZ-0747-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmEthicon, Inc., Somerville, NJ, United States
Recall initiated2018-12-18
Classified2019-01-16
Reported by FDA2019-01-23
Terminated2020-05-29
DistributedAR, CA, FL, GA, KS, LA, MO, MS, ND, NE, NJ, NY, OH, PA, WI
Quantity840
Reason classeslabeling
Lot numbersMEH906

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0747-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.