Class II — Integra LifeSciences Corp.
| Recalling firm | Integra LifeSciences Corporation |
|---|---|
| Registered facility | View this company's 15 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram |
| Product | Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000 |
| Quantity | 552 units |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Brazil, China, HONG KONG, HK, India, Shri Lanka, Mexico, Philippines, Trinidad. |
| Initiated | 2020-11-11 |
| Classified | 2020-12-08 |
| Terminated | 2021-06-17 |
| Recall number | Z-0548-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Integra LifeSciences Corp. (Z-0548-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86845/
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