STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of
FDA device recall Z-0150-2023 · posted 2022-10-31 · Open, Classified
Recall details
- Recalling firm
- Ethicon, Inc.
- Reason for recall
- Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair
- Action taken
- Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- GAM
- Quantity affected
- 2,280 eaches
- Distribution
- International distribution of the country of China.
- Date initiated
- 2022-09-20
- Date posted
- 2022-10-31
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (K151200) | ETHICON, Inc. | 2015-08-13 |