CLASS II Device recall · Reported 21 Aug 2019 · FDA Enforcement Report
Go-EZ Screw recalled by BioPro
BioPro is recalling Go-EZ Screw 6, distributed nationwide in the US. The recall was initiated on 25 Jun 2019 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-2254-2019
- FDA event ID
- 83288
- Recalling firm
- BioPro, Port Huron, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Jun 2019
- FDA classified
- 12 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Device type
- Hip & Knee Implants
Timeline
| 25 Jun 2019 | Recall initiated by company | |
| 12 Aug 2019 | Classified by FDA | +48 days |
| 21 Aug 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Manufacturing flaw in the sterile barrier system
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
Go-EZ Screw 6.5x32, Item Number 19652 - Product Usage: Accessories to the BioPro Go-Ez screw system and the BioPro HBS System. It is intended for various orthopedic surgical procedures but is not intended for use in the spine
Where it was distributed
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
Nationwide FloridaLouisianaMarylandNorth CarolinaNew YorkOregonTexas
Questions about this recall
Why was it recalled?
Manufacturing flaw in the sterile barrier system
Which lots are affected?
UDI - M209196520 Lot Number - 123106 MFG Date - 4/26/2019
Where was it sold?
Worldwide distribution - US Nationwide distribution in the states of FL, LA, MD, NC, NY, OR & TX, and countries of Ecuador, Scotland.
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
20 other products · FDA event 83288This product is part of a recall event; the main page for the event is Go-EZ Screw recalled by BioPro.
More recalls from BioPro
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Femoral Head (Ceramic heads 28-30) Product ID/Description recalled | BioPro | Sterility | MI, TX |
| Device | CLASS II | Endo Head (Metal uni-polar, 38-55) Product recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head Product ID/Description 14089 Head Femoral recalled | BioPro | Sterility | MI, TX |
| Device | CLASS II | Endo Head (Ceramic) Product ID/Description 13006 Endo recalled by BioPro | BioPro | Sterility | MI, TX |
| Device | CLASS II | Femoral Head (Metal 22, 28, 32, 36, cobalt chromium recalled by BioPro | BioPro | Sterility | MI, TX |
Other Hip & Knee Implants recalls
All 3,111| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Intellijoint Navigation System: Workstation G2 Configured recalled | Intellijoint Surgical | Device Malfunction | Nationwide |
| Device | CLASS II | Trinity Non-Surgical Isolation Gown, AAMI PB70 Level 2, X-Large recalled | New York Embroidery Studio | Packaging Defects | Nationwide |
| Device | CLASS II | Axle Pin Assy Large Elbow Cobalt Chrome recalled by Howmedica Osteonics | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Triathlon Hinge Insert Size 4 5612-p-411 Triathlon Hinge recalled | Howmedica Osteonics | Other | Nationwide |
| Device | CLASS II | Scorpio Recessed Metal Backed Patella 3045 recalled | Howmedica Osteonics | Foreign Material | Nationwide |