Z-1327-2021Class II

Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced...

Name: Z-1327-2021 Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced...
Creator: Stryker Sustainability Solutions
Published: 2021-01-19
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2021-01-19 / Open, Classified / root cause: design

FDA source

Stryker Sustainability Solutions began a recall of Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage... on 2021-01-19. FDA classified it as Class II and gives the reason as "Product was distributed without receiving regulatory clearance". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1327-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-01-19
Posted: 2021-03-31
Recalling firm: Stryker Sustainability Solutions
Product: Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery, Inc. Harmonic ACE +7, Shears with Advanced Hemostasis 5mm Diameter x 36cm - Product Usage: indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gynecologic, urologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures.
Product code: NLQ Single-Use Reprocessed Ultrasonic Surgical Instruments
Reason for recall: Product was distributed without receiving regulatory clearance.
Root cause tag: design
FDA root cause: Device Design
Action: On 01/19/2021, the firm sent an "URGENT; MEDICAL DEVICE RECALL" Notification letter its customers informing them that the affected products are currently under evaluation and do not have Regulatory Clearance and the safety and efficacy of the product has not been assessed. Customers are instructed to: 1. Discontinue use of the affected products. 2. Check their inventory for the affected products. 3. Complete the Urgent Medical Device Recall Business Reply Form and indicate if any of the affected product remains in their inventory. They are instructed to return the completed form through on of the following methods: a) Email: [email protected] b. To their Recalling Firm's Sales Representative c. Fax: 480-763-5345 The form must be completed and returned to the Recalling Firm even if no affected product is found. 4. If any of the affected products have been forwarded to additional facilities, please contact these facilities and communicate this recall to them. 5. Maintain awareness of this communication internally until all required actions have been completed with their facility. If the returned Urgent Medical Device Business Reply Forms indicated that any affected products remains in customer's inventory, a Recalling Firm Representative will contact them to arrange for the removal of the product(s). Any questions regarding this Recall - contact Post Market Surveillance Manager at 888-888-3433 or email [email protected]
Quantity in commerce: 102 units
Distribution: Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Product codes and lots: Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1327-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1327-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-04-07	2021-03-31

Product code NLQ

K161693UnclassifiedReprocessed HARMONIC ACE+7, 5 mm Diameter Shears with Advanced HemostasisStryker Sustainability Solutions / cleared 2017-02-23

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)