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Medtronic Sofamor Danek USA Inc

Medtronic Sofamor Danek USA Inc Recalls

All product recalls associated with Medtronic Sofamor Danek USA Inc.

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Recall Summary

Total Recalls

1000

Past Year

732

Class I (Serious)

175

Most Recent

Jan 2026

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 9801–9820 of 11124 recalls

Medtronic Sofamor Danek USA Inc: Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAP...

The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.

FDAFeb 6, 2009Nationwide• Medtronic Sofamor Danek USA Inc

Cyberkinetics Neurotechnology Systems, Inc.: Cyberkinetics Inserter Wand & V2 Trigger Assembly, Expira...

Sterility of product cannot be assured

FDAFeb 4, 2009Nationwide• Cyberkinetics Neurotechnology Systems, Inc.

Medtronic Spine LLC, formerly Kyphon Inc: KyphX Xpander Inflatable Bone Tamp, size 15/3, Catalog Nu...

Product not sterile: 10 units were released for distribution without undergoing sterilization process.

1...489 490491492 493...557

Page 491 of 557Next

FDA

Feb 4, 2009

FL, IN, OH

• Medtronic Spine LLC, formerly Kyphon Inc

Stryker Howmedica Osteonics Corp.: Modular Replacement System (MRS) Cemented Stems, Sterile,...

Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.

FDAJan 30, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Instruments Div. of Stryker Corporation: Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-...

Fire/Burn Risk

Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.

FDAJan 27, 2009Nationwide• Stryker Instruments Div. of Stryker Corporation

Volk Optical Inc: Optiflex Lens Positioning Unit (LPU) Product Code: 10970...

Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward.

FDAJan 23, 2009IN, MO• Volk Optical Inc

Cook Endoscopy: AcuSnare Polypectomy Soft Snare, Order number SASM-1, Wil...

The snare head is hexagonal but the handle and packaging indicate an oval reorder number.

FDAJan 21, 2009MI, NY, WI• Cook Endoscopy

Perkin Elmer: Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0...

If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay

FDAJan 15, 2009Nationwide• Perkin Elmer

Perkin Elmer: Specimen Gate Laboratory, Product Code: 5002-0180, Softwa...

FDAJan 15, 2009Nationwide• Perkin Elmer

Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics, Primary Super SecurFit Stem...

Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

FDAJan 14, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stryker Howmedica Osteonics Corp.: Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem;...

Stryker Orthopaedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.

FDAJan 14, 2009Nationwide• Stryker Howmedica Osteonics Corp.

Stork Craft Baby Cribs (Stork Craft) – Entrapment Risk (2009)

This recall involves Stork Craft Baby cribs and Stork Craft cribs with the Fisher-Price logo. All Stork Craft Baby cribs with manufacturing and distribution dates between May 2000 and November 2008 are included in this recall. All Stork Craft cribs with the Fisher-Price logo have distribution dates between May 2000 and December 2004. The cribs were sold in various styles and finishes. The manufacture date, model number, crib name, country of origin, and the firm's name, address, and contact information are located on the assembly instruction sheet attached to the mattress support board. The firm's insignia "Storkcraft baby" or "storkling" is inscribed on the drop side teething rail of some cribs. In the product that contains the "Fisher-Price" logo, this logo can be found on the crib's teething rail, in the manufacturer's instructions, on the assembly instruction sheet attached to the mattress support board, and on the end panels of the Twinkle-Twinkle and Crystal crib models.

CPSCJan 13, 2009Nationwide• Stork Craft Manufacturing Inc., of British Columbia, Canada