FDA Medical Device Recalls (openFDA)
Wright Medical Technology, Inc.: EasyFuse Dynamic Compression System Instrument Pack
- Recall number
- Z-0853-2022
- Recalling firm
- Wright Medical Technology, Inc.
- Product
- EasyFuse Dynamic Compression System Instrument Pack
- Status
- Terminated
- Initiated
- 2022-03-10
- Posted
- not on file
- Terminated
- 2026-04-01
- Reason
- The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
- 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
- 176 packs
- Distribution
- US distribution to Florida, North Carolina, Ohio, and Texas
- Lot, serial or model codes
- Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)
- 510(k) numbers
- ["K203832"]
- PMA numbers
- not on file
- Product code
- JDR
- Firm FEI
- 3010667733
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28