Z-0747-2019Class II

PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T

Name: Z-0747-2019 PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T
Creator: Ethicon, Inc.
Published: 2018-12-18
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2018-12-18 / Terminated / root cause: packaging

FDA source

Ethicon, Inc. began a recall of 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... on 2018-12-18. FDA classified it as Class II and gives the reason as "The sutures inside the packaging are not the same size or type as indicated on the label". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0747-2019
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Posted: 2019-01-16
Terminated: 2020-05-29
Recalling firm: Ethicon, Inc
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.
Product code: GAP Suture, Nonabsorbable, Silk
Reason for recall: The sutures inside the packaging are not the same size or type as indicated on the label.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Ethicon sent an Urgent Medical Device Recall notification letters to customers on 12/18/18. The letter identified the affected product, problem and actions to be taken. For questions contact Ethicon Customer Support Center at 1-877-ETHICON (1-877-384-4266).
Quantity in commerce: 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.
Product codes and lots: Product Lot MEH906

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0747-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0747-2019	Class II	Terminated	Voluntary: Firm initiated	2019-01-23	2019-01-16

Product code GAP

K946173Class IIStainless Steel, Gut, Poly (Glycolide/l-Lactide) Polyamide, Polypropylene, Poly (Ethylene Terephthalate) and SilkETHICON, Inc. / cleared 1995-01-09

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)