Instruction Manual for Mayfield A2000 Skull Cap — Class II medical device recall Z-0548-2021
Terminated recall by Integra LifeSciences Corp., reported 2020-12-16, distributed nationwide. Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position D
| Recall number | Z-0548-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Integra LifeSciences Corp., Princeton, NJ, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-12-08 |
| Reported by FDA | 2020-12-16 |
| Terminated | 2021-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CN, HK, IN, MX, PH, TT |
| Quantity | 552 units |
Product
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Reason for recall
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0548-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.