ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, Standard; Non-sterile;
FDA device recall Z-2264-2013 · posted 2013-09-21 · Terminated
Recall details
- Recalling firm
- Endoplus, Inc.
- Reason for recall
- Multiple complaints reporting that the moveable jaw has broken during laparoscopic procedures.
- Action taken
- Letters were sent on 7/15/2013 to all customers notifying them of the recall. The letters requested that customers return the recalled devices via private courier using an enclosed account number. Replacement devices will be made available upon customer request.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GCJ
- Quantity affected
- 81 units
- Distribution
- Distributed in the states of FL, TX, and VA.
- Date initiated
- 2013-07-15
- Date posted
- 2013-09-21
- Date terminated
- 2016-02-08
- Location
- Mundelein, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER) (K925079) | Endo Technic Corp. | 1994-08-24 |