FDA Device recall Z-0548-2021
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures
- FDA Device
- Class II
- terminated
- Published 2020-12-16
On 2020-12-16 the FDA classified a Class II recall of Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures by Integra Lifesciences, citing revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0548-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-11 |
| Published | 2020-12-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Integra Lifesciences |
| Distribution | US |
Product
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
Reason
Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram
Identifiers
| code_info | Rev Version B, Rev C and Rev D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0548-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.