Recall Z-0150-2023— Ethicon, Inc.

Name: FDA recall Z-0150-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-20

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2022-09-20. It names one FDA 510(k) clearance: K151200. 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 appropriate. Product No.: SXMD1B405-12. Reason: 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.

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-09-20
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K151200 — STRATAFIX Spiral MONOCRYL Knotless Tissue Control Device, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control DeviceETHICON, Inc.·cleared 2015-08-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 appropriate. Product No.: SXMD1B405-12

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.