Recall Z-0548-2021 ยท HBL Holder, Head, Neurosurgical (Skull Clamp)
Integra LifeSciences Corp.
Instruction Manual for Mayfield A2000 Skull Cap - Product Usage: intended for or rigid skeletal fixation during neurosurgical procedures. P/N: 451A2000
| Date | Nov 11, 2020 |
| Status | Terminated |
| Reason | Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram |
| Root cause | Labeling Change Control |
| Action | Integre Life Sciences issued Voluntary Medical Device Correction via fedex mailing 2day (US customers) on 11/11/2020, stating reason for recall, health risk, and action to take: Customers: a. Please review and understand the information provided on the first page of this letter. b. Review the Mayfield Skull Clamp Position Diagram in the Instruction Manual for Part# 451A2000, Rev B through D (last page of each language in Instruction Manual). c. Replace the information in Mayfield Skull Clamp Position Diagram in the Instruction Manual, Part# 451A2000 with the information provided under Accurate |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K932807 | MAYFIELD* A-2000 SKULL CLAMP Ohio Medical Instrument Co., Inc., Sep 28, 1993 |