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Walter Lorenz Surgical, Inc.

United StatesFDA applicant, unverified

Devices
56
FDA recalls
3

What Walter Lorenz Surgical, Inc. makes

Walter Lorenz Surgical, Inc. manufactures orthopedic and maxillofacial fixation devices, including mini bone plates and screws, distraction systems for mandibular and maxilla (Le Fort) bone growth, and pectus support bars. Their portfolio also covers surgical instruments like monopolar and bipolar cautery tools, as well as specialized implants such as lactosorb tap-free screws and a titanium stent. Additionally, they produce a xenon light source for surgical illumination and an otomix device for ear-related procedures.

The company’s devices are classified under FDA categories Class I and Class II, with most requiring 510(k) clearance. Products are listed in the FDA’s 510(k) registry, reflecting their regulatory compliance in the United States. The manufacturer operates from the US.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue56

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FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 3 recalls initiated by Walter Lorenz Surgical, Inc., initiated on 2006-02-17. By recorded status: 3 terminated. The reasons filed fall into these groups: mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2006

    • 17 Feb 2006 Z-0383-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much. Distribution: Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan. Submission number: K002083
    • 17 Feb 2006 Z-0384-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much. Distribution: Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan. Submission number: K002083
    • 17 Feb 2006 Z-0385-2012 Unclassified (pre-2012) Terminated Lorenz Engineer discovered flex tube could break if bent too much. Distribution: Worldwide Distribution - USA (nationwide) including the states of: GA and TX and the country of Japan. Submission number: K002083