🍔 Food 💊 Drugs 🏥 Medical Devices
AlternatiV+ Max Knotless Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Genesis Push-In Suture Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Genesis Knotless Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Genesis Dual Thread Screw-In Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Genesis Screw-In Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Fixone Biocomposite Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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Fixone Hybrid Anchor Class II

Reason: Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.

Aju Pharm Co., Ltd. 20251217 Ongoing
Distributed: US Nationwide distribution in the states of CA & PR.
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PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft, 1.0cc REF: 730-010 Class II

Reason: Incorrect expiration date

Cerapedics, Inc. 20251229 Ongoing
Distributed: US Nationwide distribution in the states of CA, CO, CT, FL, GA, ID, IL, KS, LA, MI, MN, MO, MT, NE, NJ, NV, NY, OH,OR, PA, TN, TX, WA, WY.
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Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Component: No Class II

Reason: Due to a manufacturing issue and electrical grounding of systems.

Elekta, Inc. 20251214 Ongoing
Distributed: Worldwide
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Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no Class I

Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.

SunMed Holdings, LLC 20251215 Ongoing
Distributed: Worldwide distribution - US Nationwide and the countries of Canada, Hong Kong, and Singapore.
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