Drugs & medicalClass II

Medtronic Sofamor Danek USA Inc recalls Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT…

Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be…

Read the official notice →
Date
2025-12-03
Country
United States
Brand
Medtronic Sofamor Danek
Product
Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT…
Classification
Class II
Units
Worldwide distribution - US Nationwide and Puerto Rico. The countries of…
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Medtronic Sofamor Danek recalls

  1. 2023-11-01
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    Medtronic Sofamor Danek USA Inc recalls Grafton DBM (Flex), Model Numbers: T42100, Demineralized Bone Matrix

    Specific serial numbers of GraftonTM DBM product due to the potential that a step during the inspection of the outer Tyvek pouch may not have been performed according to requirements. Based on this, batches may have…

    FDA · DeviceMedtronic Sofamor Danek USA IncUS, Colombia, S. Korea, New Zealand, India, TaiwanOfficial notice →
  3. 2023-09-20
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    Medtronic Sofamor Danek USA Inc recalls Magnifuse Bone Graft, Large, Size: 14mm x 25mm, REF 7509014, Human Tissue, Demineralized Bone Matrix, sterile.

    The incorrect product labeling was applied to the product indicating the wrong size of product.

    FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of ID, IN, MN, NC, NY, OH, OR, WA,…Official notice →
  5. 2023-08-16
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    Medtronic Sofamor Danek USA, Inc recalls CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K

    Incorrect Laser Marking - Solera Awl Tip Tap

    FDA · DeviceMedtronic Sofamor Danek USA, IncUS Nationwide distribution in the states of FL, CO, IN, SC, TX, UT.Official notice →
  7. 2023-07-19
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    Medtronic Sofamor Danek USA Inc recalls Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Standalone Cage, REF SPS03188, spinal implant kit

    There is the potential for out of specification device geometries. widths, lengths, heights, and lordotic angles to accommodate patient anatomy. These devices can be inserted between two lumbar or lumbosacral vertebral…

    FDA · DeviceMedtronic Sofamor Danek USA IncUS Nationwide distribution in the states of IN, WI, GA, OR, AR, OH, TN, TX,…Official notice →
  9. 2023-05-17
  10. US
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    Medtronic Sofamor Danek USA Inc recalls Distractor Rack, REF 5598007, which may be packaged in Modular Distractor Set, Loaner Kit Number SPS03139; for use in spinal…

    Two lots of the 5598007 Distractor Rack which were not manufactured to specification. The crest width of the gear is too wide and may cause difficulty or the inability to operate the Distractor.

    FDA · DeviceMedtronic Sofamor Danek USA IncUS: IN, CT, NEOfficial notice →
  11. 2023-04-26
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    Medtronic Sofamor Danek USA Inc recalls INFINITY Occipitocervical Upper Thoracic System, MULTI AXIAL SCREW, Size: 4.0mm x 24mm, REF 3604024; for immobilization and…

    Incorrect type of titanium was used which reduces the gripping strength of the screw head of 5 batches of Infinity Multi-Axial Screws

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All 9 Medtronic Sofamor Danek recalls →

Other drugs & medical recalls in the United States

  1. 2025-12-03
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    DERMASENSOR INC recalls DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Software-aided adjunctive diagnostic device for use by physicians on…

    Potential for device to not meet specifications resulting in incorrect results or delay of referral for patients.

    FDA · DeviceDERMASENSOR INCUS distribution to MD, FL, AZ, MS, PA, NY, CT, CA.Official notice →
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    Straumann USA LLC recalls Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10;

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    XXX

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See all drugs & medical recalls →