Synthes (USA) Products LLC recalls Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
Products not sterilized, sterility cannot be confirmed
Read the official notice →- Date
- 2024-03-13
- Country
- United States
- Brand
- Synthes (USA) Products
- Product
- Opal, Intervertebral Cage, 10x32mm, h 11mm, Revolvable-Indicated for degenerative spine disease Part Number: 08.803.231S
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Argentina,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Synthes (USA) Products recalls
- 2026-04-08
USSynthes (USA) Products LLC recalls 2.4 VOLT TAP LOCKING SCREW TAP TO 90MM. Part Number: 03.424.124-US.
A full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps having an incorrect thread.
FDA · DeviceSynthes (USA) Products LLCUS Nationwide distribution in the states of AR, AZ, CA, CO, FL, IN, LA, MD,…Official notice →- 2025-10-29
- US
Synthes (USA) Products LLC recalls LOW PROF LCKNG SCREW, F/IM NAIL 5.0MM / L, 46MM / XL25/ STER. Product Code: 04.045.346TS. Used in RFN-ADVANCEDTM Retrograde Femoral…
Although the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged and labeled as 46mm, while 46mm screws were packaged and labeled as…
FDA · DeviceSynthes (USA) Products LLCWorldwide - US Nationwide distribution in the states of AL, AR, AZ, CA, FL,…Official notice → - 2024-06-05
- US
Synthes (USA) Products LLC recalls STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening, loosening, or removing of screw implants during…
Stardrive Screwdrivers manufactured without a 5-degree relief cut around the tip and will not engage with their respective 1.3mm and 1.5mm screws, may result in surgical delay
FDA · DeviceSynthes (USA) Products LLCWorldwide distribution - US Nationwide and the country of Canada.Official notice → - 2023-03-22
- US
Synthes (USA) Products LLC recalls TFN-Advanced Femoral Nail 12MM/125 DEG TI CANN TFNA 200MM STERILE. Intended for temporary fixation and stabilization of proximal femur…
TFNA Femoral Nails labeled and etched as 200mm may measure 170mm in length, and TFNA Femoral Nails labeled and etched as 170mm may measure 200mm in length
FDA · DeviceSynthes (USA) Products LLCWorldwide - US Nationwide distribution in the states of MS, OR, TX and the…Official notice → - 2022-10-26
- US
Synthes (USA) Products LLC recalls SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910
The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide…
- 2022-10-12
- US
Synthes (USA) Products LLC recalls Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001
Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a packaging error, result in a surgical delay and may cause soft tissue damage if a larger incision is required to accommodate…
Other drugs & medical recalls in the United States
- 2024-03-13
- US
Invacare Corporation recalls Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component Model Numbers: (1) G50 (2) G53 (3) G54 (4) BAR5490IVC (5)…
Invacare Homecare & G-Series Bed Components identified with a potential weld defect leads to premature weld failures to occur on these components
- US
Canon Medical System, USA, INC. recalls MRI system: Vantage Elan, Model: MRT-2020
For some MRI systems, it has been found that some of the maximum Spatial Field Gradient (SFG) values displayed in "System Information" of the operation window and some of the maximum SFG values described in the safety…
FDA · DeviceCanon Medical System, USA, INC.Worldwide - US Nationwide distribution including in the states of MD, IL, WV,…Official notice → - US
Aesculap Inc recalls DISP.HASSON TROCAR 10/110MM, Product Code EK230SU. For use in laparoscopic procedures.
The sterile blister packaging may be damaged, and sterility may be compromised.
FDA · DeviceAesculap IncWorldwide - US Nationwide distribution in the states of KS, NJ and NY. The…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System Catalog Nos. 6802413 (regular) and 6802915 (refurbished)
A software defect affecting VITROS Systems running VITROS Software Versions 3.8.1 causes QC baseline statistics to not update as expected when changed by the user. This may cause erroneous patient results to be reported.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide - US Nationwide distribution in the states of AZ, CA, CT, FL, IA,…Official notice → - US
CareFusion 303, Inc. recalls BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
Automated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in delays in medication access, and…
FDA · DeviceCareFusion 303, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS 5600 Integrated System (New and Refurbished)
Potential For Aspiration from Unintended Sample Container During Sampling Center Processing on VITROS¿ 3600 Immunodiagnostic Systems and VITROS¿ 5600/XT 7600 Integrated Systems which may lead to erroneous test results.
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →