CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Orthofix Catalogue Number: ref 1355001, drill bit diameter 2.7 MM recalled
Orthofix is recalling Orthofix Catalogue Number: ref 1355001, drill bit diameter 2.7 MM, distributed in 29 states. The recall was initiated on 27 Sep 2018 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0379-2020
- FDA event ID
- 84004
- Recalling firm
- Orthofix, Veronaverona, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Sep 2018
- FDA classified
- 14 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 27 Sep 2018 | Recall initiated by company | |
| 14 Nov 2019 | Classified by FDA | +413 days |
| 20 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137
Where it was distributed
US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
ArizonaCaliforniaFloridaGeorgiaHawaiiIowaIllinoisIndianaKentuckyLouisianaMarylandMichiganMissouriMississippiNorth CarolinaNew YorkOhioOklahomaOregonPennsylvania
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot # B1215075, 303106, 289822, 273357
Where was it sold?
US: AZ, CA,FL,GA,HI,IA,IL,IN,KY,LA,MD,MI,MO,MS,NC,NY,OH,OK,OR,PA,SC,TN,TX,UT,VA,WA, WI, WV, Puerto Rico OUS: Kuwait, Australia, Saudi Arabia, United Arab Emirates, Ireland, Japan, Spain, Poland, Switzerland, Singapore, Peru, Brazil, Germany, Great Britain, France, Italy, Australia, South Africa, Belgium, Chile, The Netherlands, Lithuania, Sri Lanka, Denmark, Israel
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
30 other products · FDA event 84004This product is part of a recall event; the main page for the event is Orthofix Catalogue Number: ref 1100701, drill bit diameter 4.8 MM recalled.
More recalls from Orthofix
All 65| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled | Orthofix | Other | N/A |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-91647, US Xcaliber Ankle Complete recalled | Orthofix | Device Malfunction | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref 1-1100301,Drill BIT Diameter recalled | Orthofix | Device Malfunction | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled | Orthofix | Device Malfunction | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-92503, Prefix II Diaphyseal recalled | Orthofix | Device Malfunction | 29 states |
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