SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Read the official notice →- Date
- 2025-01-01
- Country
- United States
- Brand
- Seaspine Orthopedics
- Product
- Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Seaspine Orthopedics recalls
- 2026-07-29
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Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice →- 2025-12-24
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FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ,…Official notice → - 2025-09-17
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SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
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FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH,…Official notice → - 2024-07-24
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SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description:…
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONThe product was distributed to the following US states: Nevada, Colorado,…Official notice → - 2024-07-10
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product…
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUnited States Nationwide distribution in the states of Nevada, Texas,…Official notice → - 2024-05-01
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which…
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Other drugs & medical recalls in the United States
- 2025-01-01
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Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600K
Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
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Abbott Medical recalls The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates…
Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a loss of telemetry during a small window (<2 seconds) may cause the…
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Becton, Dickinson and Company, BD Bio Sciences recalls FACSLyric 2L4C Instrument US, Catalog Number 662875, UDI 00382906628756 BD FACSLyric" flow cytometer is intended…
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