Z-0781-2020Class II

Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm...

Name: Z-0781-2020 Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm...
Creator: Stryker GmbH
Published: 2019-11-21
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2019-11-21 / Terminated

FDA source

Stryker GmbH began a recall of 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... on 2019-11-21. FDA classified it as Class II and gives the reason as "Pin To Rod Coupling could not clamp the pin and rod as intended". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0781-2020
Classification: Class II
Status: Terminated
Initiated: 2019-11-21
Posted: 2020-01-07
Terminated: 2020-11-13
Recalling firm: Stryker Corp.
Product: 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
Product code: JEC Component, Traction, Invasive
Reason for recall: Pin To Rod Coupling could not clamp the pin and rod as intended
FDA root cause: Under Investigation by firm
Action: 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
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 codes and lots: Lot Number: D30875 UDI : (01)07613327089158(10)D30875

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0781-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0781-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-15	2020-01-07

Product code JEC

K102885Class IIHoffmann II External Fixation System Line Extension Model 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, Hoffmann II ExStryker Corp. / cleared 2011-01-14

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)