Recall Z-1775-2013— Ethicon Endo-Surgery Inc
Class II · Terminated
Class II FDA medical device recall by Ethicon Endo-Surgery Inc, initiated 2013-04-12, terminated 2014-05-01. It names 3 FDA 510(k) clearances: K864102, K830503, K812291. Product: LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.. Reason: Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure.
- Recalling firm
- Ethicon Endo-Surgery Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-04-12
- Terminated
- 2014-05-01
- Firm location
- Cincinnati, OH, United States
510(k) clearances named in this recall
3 on FDA's record- K864102 — LIGACLIP 20/20* MULTIPLE CLIP APPLIER
- K830503 — LIGACLIP TITANIUM LIGATING CLIP
- K812291 — ETHICON MULTIPLE LIGATING CLIP APPLIER
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH¿ surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360¿ in either direction. The rotating knob is located to allow for a one-handed technique.
Reason for recall
Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Data sourced from openFDA. This site is unofficial and independent of the FDA.