Insorb Subcuticular Skin Stapler. INSORB staples are made from an absorbable copolymer which is a synthetic polyester de
FDA device recall Z-1545-2015 · posted 2015-04-29 · Terminated
Recall details
- Recalling firm
- Incisive Surgical Inc
- Reason for recall
- A previous Turkish distributor over-labeled a portion of the lot with an expiration date of 2016-05. The expiration date at the time of manufacturing was 2014-05.
- Action taken
- Firm is working with EU Rep on English and Turkish notification letters.
- Root cause
- Labeling False and Misleading
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 210 cartons (containing 6 INSORB staplers per carton)
- Distribution
- International Distribution Only - Turkey.
- Date initiated
- 2015-03-19
- Date posted
- 2015-04-29
- Date terminated
- 2015-07-08
- Location
- Plymouth, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| INSORB ABSORBALBE STAPLE (K120373) | Incisive Surgical, Inc. | 2012-03-16 |
| INSORB ABSORBABLE STAPLE, MODEL 1020, 1025, AND OTHER PRODUCT FAMILIES (K090159) | Incisive Surgical, Inc. | 2009-02-06 |
| INSORB ABSORBABLE STAPLE, MODEL 1020 (K061784) | Incisive Surgical, Inc. | 2006-07-26 |
| INSORB ABSORBABLE STAPLE, MODEL SP-B20 (K033602) | Incisive Surgical, Inc. | 2003-12-16 |
| INSORB ABSORBABLE STAPLES, MODEL SP-B20 (K024117) | Incisive Surgical, Inc. | 2003-04-22 |