Z-1848-2017Class II
Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde...
Smith & Nephew, Inc. / initiated 2017-03-15 / Terminated / root cause: design
Smith & Nephew, Inc. began a recall of Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore... on . FDA classified it as Class II and gives the reason as "Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1848-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Smith & Nephew, Inc.
- Product
- Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone
- Product code
- GFG Bit, Surgical
- Reason for recall
- Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming
- Root cause tag
- design
- FDA 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 [email protected]. For questions regarding this recall call 508-261-3600.
- Distribution
- Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE
- Product codes and lots
- Batch Numbers: G10802 ,G10804, G18818
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1838-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1839-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1840-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1841-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1842-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1843-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1844-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1845-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1846-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1847-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1848-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1849-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1850-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1851-2017 | Class II | Terminated | Voluntary: Firm initiated |
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