HOFFMANN recallZ-0781-2020 · Stryker GmbH · initiated Nov 21, 2019
Terminated
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 GmbH 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
Pin To Rod Coupling could not clamp the pin and rod as intended
FDA root cause category: Under Investigation by firm
What the company is doing
Stryker issued Urgent Medical Device Recall - PFA 2227937 letter on November 21, 2019 to affected US consignees by third-party recall company, Stericycle Inc. (2670 Executive Drive Indianapolis, IN 46241), via UPS 2nd day air. An OUS customer letter was also issued at the country level. The letter states reason for recall, health risk and action to take: Actions Needed: 1.Please inform users of this Urgent Medical Device Recall and forward this notice to all those individuals who need to be aware within your organization. 2.Immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility. A response is required, even though you may not have any physical inventory on site anymore. 3.Quarantine and discontinue use of the recalled devices. 4.Hospitals/Branches/Agencies: Complete and sign the enclosed Urgent Medical Device Recall Business Reply Form and fax a copy to 1-844-782-5565 or email to [email protected] 5.Hospitals/Branches/Agencies: Return all affected instruments available at your location to the following address. Stryker Orthopaedics/PFA Product Returns PFA 2227937 Attn: Distribution Inventory Team 325 Corporate Drive Dock M-East Mahwah, NJ 07431
Recall details
- Recall number
- Z-0781-2020
- Status
- Terminated
- Initiated by the company
- Nov 21, 2019
- Recalling firm
- Stryker GmbH
- Product code
- JEC
- FDA submissions
- K102885
- Distribution
- Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.
Product description
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
Code information (models, lots, serial numbers)
Lot Number: D30875 UDI : (01)07613327089158(10)D30875
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- HOFFMANN 4940-1-020Stryker GmbH · COMPONENT, TRACTION, INVASIVE1 recall1 report
Product lines
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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