Recall Z-0373-2020— Orthofix Srl
Class II · Terminated
Class II FDA medical device recall by Orthofix Srl, initiated 2018-09-27, terminated 2022-02-01. It names one FDA 510(k) clearance: K955848. Product: ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959. Reason: As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance..
- Recalling firm
- Orthofix Srl
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-09-27
- Terminated
- 2022-02-01
- Firm location
- Veronaverona, N/A, Italy
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959
Reason for recall
As a result of complaint investigations it was determined that batches of drill bits have a geometrical detail that does not correspond to the intended design. This could result in lower cutting performance.
Data sourced from openFDA. This site is unofficial and independent of the FDA.