Stryker Sustainability Solutions: 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.

Recall number

Z-1327-2021

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.

Status

Open, Classified

Initiated

2021-01-19

Posted

not on file

Terminated

not on file

Reason

Product was distributed without receiving regulatory clearance.

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: SSSPFA@stryker.com 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 Marissa.richmond@stryker.com

Quantity

102 units

Distribution

Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.

Lot, serial or model codes

Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050

510(k) numbers

["K161693"]

PMA numbers

not on file

Product code

NLQ

Firm FEI

3009350690

Firm city

Tempe

Firm state

AZ

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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