FDA Medical Device Recalls (openFDA)
SURGICAL SPECIALTIES: POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
- Recall number
- Z-1534-2024
- Recalling firm
- SURGICAL SPECIALTIES
- Product
- POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
- Status
- Open, Classified
- Initiated
- 2024-03-26
- Posted
- 2024-04-12
- Terminated
- not on file
- Reason
- Complaints have been received with allegations of Incorrect Needle Curvature.
- Root cause
- Process control
- Action
- On March 26, 2024 customers were sent URGENT MEDICAL DEVICE RECALL letters via email. The letters instructed customers to immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of the product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter and the acknowledgement form for product return. We kindly request the return of any affected product that may still be in your stock inventory, and we will replace the product at no charge. If you have any questions, contact complaints@corza.com.
- Quantity
- 2,459 units
- Distribution
- Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
- Lot, serial or model codes
- Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
- 510(k) numbers
- ["K965162"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 3016050589
- Firm city
- Westwood
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28