CLASS II ONGOING Device recall · Reported 7 Apr 2021 · FDA Enforcement Report
Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery recalled
Stryker Sustainability Solutions is recalling Stryker Sustainability Solutions, distributed nationwide in the US. The recall was initiated on 19 Jan 2021 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1327-2021
- FDA event ID
- 87434
- Recalling firm
- Stryker Sustainability Solutions, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Jan 2021
- FDA classified
- 31 Mar 2021
- Reported
- 7 Apr 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Device type
- Hip & Knee Implants
Timeline
| 19 Jan 2021 | Recall initiated by company | |
| 31 Mar 2021 | Classified by FDA | +71 days |
| 7 Apr 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product was distributed without receiving regulatory clearance.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
Questions about this recall
Is Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery recalled?
Yes. Stryker Sustainability Solutions recalled Stryker Sustainability Solutions REF HARH36 Ethicon Endo-Surgery on 19 Jan 2021. The recall is Class II and its status is Ongoing. Recall number Z-1327-2021.
Why was it recalled?
Product was distributed without receiving regulatory clearance.
Which lots are affected?
Catalog Number: HARH36 GTIN: 07613327346251 Lot Number: 12444050
Where was it sold?
Worldwide distribution - U.S. Nationwide distribution in the state of OH and the country of Israel.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Daig Livewire Steerable, Product Number recalled | Stryker Sustainability Solutions | Sterility | Nationwide |
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |