Stratafix Spiral Pga-pcl UNI UD recall
STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code…
Why was Stratafix Spiral Pga-pcl UNI UD recalled?
Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049
- Product
- STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2808 (all OUS)
- Distribution
- International distribution in the country of China.
- Recall date
- May 18, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)