FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
- Recall number
- Z-1845-2017
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
- Status
- Terminated
- Initiated
- 2017-03-15
- Posted
- not on file
- Terminated
- 2018-07-10
- Reason
- Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- Root cause
- Device Design
- Action
- Smith &n Nephew sent an Urgent Medical Device Recall Notice dated March 15, 2017, to all affected customers via Federal Express. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return product and to follow instructions on the attached Response Form. Customers with questions were instructed to email FieldActions@smith-nephew.com. For questions regarding this recall call 508-261-3600.
- Quantity
- not on file
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
- Lot, serial or model codes
- Batch Numbers: F86213 ,F86216 , G04654, G04655, G04656, G10376 G10377, G11224, G11226, G11237, G11238, G15935, G15936, G15937, G18822, G18823, G18824, G18826, G18837, G18838, G18840, G18841, G30215, G30216, G30247, G30248, G30256, G32169, G32173, G32174 G32175, G32176, G32177
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GFG
- Firm FEI
- 1219602
- Firm city
- Mansfield
- Firm state
- MA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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