CLASS II Device recall · Reported 20 Nov 2019 · FDA Enforcement Report
Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled
Orthofix Srl is recalling Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX, 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-0396-2020
- FDA event ID
- 84004
- Recalling firm
- Orthofix Srl, 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
- Sterility
- 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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
ORTHOFIX Catalogue Number: ref: 99-93501US, PELVIS STERILE KIT, RX ONLY, UDI: (01)180S4242S11281
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
Is Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX recalled?
Yes. Orthofix Srl recalled Orthofix Catalogue Number: ref: 99-93501US, Pelvis Sterile KIT, RX on 27 Sep 2018. The recall is Class II and its status is Terminated. Recall number Z-0396-2020.
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 # B1225391
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Orthofix Srl
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile recalled | Orthofix Srl | Sterility | N/A |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-91647, US Xcaliber Ankle Complete recalled | Orthofix Srl | Device Malfunction | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref 1-1100301,Drill BIT Diameter recalled | Orthofix Srl | Sterility | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-92503, Prefix II Diaphyseal recalled | Orthofix Srl | Sterility | 29 states |
| Device | CLASS II | Orthofix Catalogue Number: ref: 99-93504, Elbow Sterile KIT, UDI recalled | Orthofix Srl | Sterility | 29 states |
Other Other Medical Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Blood Draw Kit recalled by Medline Industries | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep Clear recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Ortho Aspiration Kit recalled | Medline Industries | Sterility | Nationwide |
| Device | CLASS II | Medline Convenience Kits containing BD ChloraPrep DYKA1054F recalled | Medline Industries | Lead & Heavy Metals | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Arterial Line Insertion Kit recalled | Medline Industries | Sterility | Nationwide |