Stryker Sustainability Solutions REF HARH36 Ethicon… recallZ-1327-2021 · Stryker Sustainability Solutions · initiated Jan 19, 2021
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Stryker Sustainability Solutions or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product was distributed without receiving regulatory clearance.
FDA root cause category: Device Design
What the company is doing
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]
Recall details
- Recall number
- Z-1327-2021
- Status
- Open, Classified
- Initiated by the company
- Jan 19, 2021
- Recalling firm
- Stryker Sustainability Solutions
- Quantity
- 102 units
- Product code
- NLQ
- FDA submissions
- K161693
- Distribution
- Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Product description
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.
Code information (models, lots, serial numbers)
Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- N/AStryker Sustainability Solutions, Inc. · Scalpel, ultrasonic, reprocessed1 recall94 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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