Z-0853-2022Class II

EasyFuse Dynamic Compression System Instrument Pack

Name: Z-0853-2022 EasyFuse Dynamic Compression System Instrument Pack
Creator: Wright Medical Technology, Inc.
Published: 2022-03-10
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2022-03-10 / Terminated / root cause: design

FDA source

Wright Medical Technology, Inc. began a recall of EasyFuse Dynamic Compression System Instrument Pack on 2022-03-10. FDA classified it as Class II and gives the reason as "The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0853-2022
Classification: Class II
Status: Terminated
Initiated: 2022-03-10
Posted: 2022-03-31
Terminated: 2026-04-01
Recalling firm: Wright Medical Technology Inc
Product: EasyFuse Dynamic Compression System Instrument Pack
Product code: JDR Staple, Fixation, Bone
Reason for recall: The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Root cause tag: design
FDA root cause: Device Design
Action: A recall notice was disseminated to the distributor and sales representatives via email (09-Mar-2022 and 10-Mar-2022) and to the hospitals via mail (10-Mar-2022, FedEx Priority Overnight). The hospital letters were delivered on 11-Mar-2022. Customers were instructed to immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility and remove them from their point of use. They are to return the enclosed business reply form by email to confirm receipt of the notification/document product segregation. Upon receipt of the completed business reply form, Stryker will arrange for the return and replacement of the product(s). Effectiveness checks will be performed through the confirmation of the returned/signed acknowledgement form.
Quantity in commerce: 176 packs
Distribution: US distribution to Florida, North Carolina, Ohio, and Texas
Product codes and lots: Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0853-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0853-2022	Class II	Terminated	Voluntary: Firm initiated	2022-04-06	2022-03-31

Product code JDR

K203832Class IIFuseForce™ Flex Dynamic Compression SystemWright Medical / cleared 2021-05-07

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)