EasyFuse recallZ-0853-2022 · Wright Medical Technology, Inc. · initiated Mar 10, 2022
Class II 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 Wright Medical Technology, Inc. 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
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-0853-2022
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 10, 2022
- Recalling firm
- Wright Medical Technology, Inc.
- Quantity
- 176 packs
- Product code
- JDR
- FDA submissions
- K203832
- Distribution
- US distribution to Florida, North Carolina, Ohio, and Texas
Product description
EasyFuse Dynamic Compression System Instrument Pack
Code information (models, lots, serial numbers)
Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EasyFuse FFSP1530Wright Medical Technology, Inc. · Orthopedic manual surgical instrument1 recall0 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K203832 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- EasyFuse™ FFS4MTPSWright Medical Technology, Inc. · Staple, fixation, bone1 report
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 18, 2026. Text above is shown as published by the FDA.
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