FDA Device recall Z-0521-2014
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000
- FDA Device
- Class II
- terminated
- Published 2013-12-25
On 2013-12-25 the FDA classified a Class II recall of Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000 by Intuitive Surgical, citing firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0521-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-15 |
| Published | 2013-12-25 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Intuitive Surgical |
| Distribution | US |
Product
Large Needle Driver, 8MM assembly of the da Vinci S IS1200 and da Vinci Si, IS2000. Manufactured by Intuitive Surgical, Sunnyvale, CA. EndoWrist Instruments, including scissors, scalpels, forceps, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing. Mega Needle Driver and Large Needle Driver instruments are part of the EndoWrist instrument family and are intended for use in endoscopic manipulation and suturing.
Reason
Firm has become aware of the potential for detachment of the jaw insert for Large Needle Drivers and Mega Needle Drivers.
Identifiers
| code_info | Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M1009110…Part number 400006 on da Vinci IS1200; Lot numbers: 710182 801282 805131 M10080716 M10080910 M10090216 M10091104 M10100728 S10080613 710192 802042 805221 M10080718 M10081014 M10090225 M10091110 M10100729 S10080618 710262 802052 805271 M10080721 M10081024 M10090325 M10091113 M10100804 S10080624 710301 802061 910072 M10080722 M10081027 M10090325 M10091120 M10100810 S10080626 710302 802072 1610072 M10080723 M10081028 M10090401 M10091130 M10100813 S10080708 711052 802082 M10080603 M10080724 M10081029 M10090407 M10091209 M10100820 S10080709 711062 802122 M10080603 M10080725 M10081031 M10090415 M10091211 M10100902 S10080711 711072 802131 M10080603 M10080728 M10081104 M10090417 M10091214 M10100924 S10080712 711082 802152 M10080605 M10080729 M10081110 M10090427 M10091216 M10100927 S10080715 711092 802202 M10080606 M10080730 M10081111 M10090505 M10100113 M10100929 S10080718 711122 802212 M10080609 M10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0521-2014%22
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