RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Reported: May 26, 2021 Initiated: March 22, 2021 #Z-1632-2021
Product Description
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US
Reason for Recall
Products labeled as sterile were distributed, but may not have been sterilized.
Details
- Recalling Firm
- BIOPSYBELL S.R.L.
- Units Affected
- 60 units
- Distribution
- US Nationwide distribution in the states MS and KY.
- Location
- Mirandola, N/A
Frequently Asked Questions
What product was recalled? ▼
RENOVA SPINE BONE FILLER 10G 12CM CENTIM. STERILE, RESFIL1112C1-US. Recalled by BIOPSYBELL S.R.L.. Units affected: 60 units.
Why was this product recalled? ▼
Products labeled as sterile were distributed, but may not have been sterilized.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 26, 2021. Severity: Moderate. Recall number: Z-1632-2021.
Related Recalls
FDA Devices Moderate
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.2…
Vortex Surgical Inc. · 2026-02-11
FDA Devices Moderate
COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conju…
Beckman Coulter, Inc. · 2026-02-11
FDA Devices Moderate
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These inst…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These in…
Olympus Corporation of the Americas · 2026-02-11
FDA Devices Moderate
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Produc…
Fujirebio Diagnostics, Inc. · 2026-02-11