Recalls / —
—#192433
Product
EasyFuse Dynamic Compression System Instrument Pack
- FDA product code
- JDR — Staple, Fixation, Bone
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K203832
- Affected lot / code info
- Model Number FFSP1530, UDI: 00889797103565 Lot Codes (Expiration Date): 781853-110321 (11/03/2029) and 780395-112221 (12/03/2029)
Why it was recalled
The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking.
Root cause (FDA determination)
Device Design
Action the firm took
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.
Recalling firm
- Firm
- Wright Medical Technology, Inc.
- Address
- 1023 Cherry Rd, Memphis, Tennessee 38117-5423
Distribution
- Distribution pattern
- US distribution to Florida, North Carolina, Ohio, and Texas
Timeline
- Recall initiated
- 2022-03-10
- Terminated
- 2026-04-01
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #192433. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.