STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. recall
STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is…
Why was STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. recalled?
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
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?
UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026
- Product
- STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is…
- Recalling firm
- Ethicon, Inc.
- Quantity
- 2,280 eaches
- Distribution
- International distribution of the country of China.
- Recall date
- November 9, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)