POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Summary
The FDA issued a Class II for POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N by SURGICAL SPECIALTIES. Reason: Complaints have been received with allegations of Incorrect Needle Curvature..
Details
Source
Device Recall
External ID
Z-1534-2024
Action Date
2024-04-24
Status
Ongoing
Category
device
Product Description
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Lot/Code Info: Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
Quantity Affected: 2,459 units
Reason for Recall
Complaints have been received with allegations of Incorrect Needle Curvature.
Distribution
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-26
Company
Westwood, MA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 179 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SURGICAL SPECIALTIES) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SURGICAL SPECIALTIES have FDA actions?
This is the only FDA action we have on record for SURGICAL SPECIALTIES in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1534-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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