Z-2889-2016Class II

ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)

Name: Z-2889-2016 ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Creator: Ethicon, Inc.
Published: 2016-08-01
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2016-08-01 / Terminated / root cause: labeling and UDI

FDA source

Ethicon, Inc. began a recall of ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) on 2016-08-01. FDA classified it as Class II and gives the reason as "ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2889-2016
Classification: Class II
Status: Terminated
Initiated: 2016-08-01
Posted: 2016-09-27
Terminated: 2017-11-29
Recalling firm: Ethicon, Inc
Product: ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature)
Product code: KDC Instrument, Surgical, Disposable
Reason for recall: ETHICON MERSILENE" Tape (also referred to as MERSILENETM Polyester Fiber Strip or MERSILENETM Fiber Ligature) products are being recalled since a group of MERSILENE" Tape product codes are being supplied with an incorrect Instructions for Use (IFU) insert.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Ethicon Inc. sent an Urgent - Medical Device Correction Notification dated August 1, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. ACTION REQUIRED: 1. Examine your inventory immediately to determine if you have product subject to this correction on hand and locate such product(s). Refer to Attachment 2 for the Product Identification Tool to identify the products that are subject to this correction by using package labels. 2. Please read Attachment 1 included within this letter thoroughly - MERSILENE" Tape Instructions for Use (IFU). 3. Ensure all users are aware of the issue by distributing this notice to all users of the Ethicon MERSILENE" Tape devices in your facility. 4. Replace the existing incorrect MERSILENE" Suture Instructions for Use (IFU) with the MERSILENE"Tape Instructions for Use (IFU) provided in Attachment 1 and dispose of the incorrect MERSILENE" Suture Instructions for Use (IFU) per your internal procedures. 5. Complete the Business Reply Form (BRF) (Attachment 3) confirming receipt of this notice and fax or email it to Stericycle at 1- (866) 723-2836 or [email protected] within three (3) business days. Please return the BRF even if you do not have product subject to this correction. 6. Keep this notice visibly posted with product subject to this correction in your facility for awareness. For further questions, please call (908) 218-0707.
Quantity in commerce: 396,024 eaches
Distribution: Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico.
Product codes and lots: All unexpired lots MERSILENE" RS20 MERSILENE" RS21 MERSILENE" RS22 MERSILENE" RS23 MERSILENE" D10076 MERSILENE" D10117 MERSILENE" D5789 MERSILENE" D7164 MERSILENE" D8014 MERSILENE" D8062 MERSILENE" D8113 MERSILENE" D9212

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2889-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2889-2016	Class II	Terminated	Voluntary: Firm initiated	2016-10-05	2016-09-27

Product code KDC

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)