Recall Z-1849-2017
Smith & Nephew, Inc. · initiated March 15, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
Codes / lots: Batch Numbers: G15888, G15934, G18833
Reason for recall
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
FDA-determined cause: Device Design
Action taken
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.
Details
- Recall number
- Z-1849-2017
- Initiated
- March 15, 2017
- Terminated
- July 10, 2018
- Product code
- GFG – Bit, Surgical
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
- Recalling firm
- Smith & Nephew, Inc., Mansfield, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1838-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1839-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1840-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1841-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1842-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1843-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1844-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1845-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1846-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1847-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1848-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1850-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |
| Z-1851-2017 Class II | Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX…Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during… | 03/15/2017Terminated |