Recall Z-1053-2022— Ethicon, Inc.

Name: FDA recall Z-1053-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-24

Class II · Ongoing

Class II FDA medical device recall by Ethicon, Inc., initiated 2022-03-24. It names one FDA 510(k) clearance: K122898. 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: SXMD1B100-12].. Reason: Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-03-24
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K122898 — QUILL MONODERM KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGNSurgical Specialties Corp. Dba Angiotech·cleared 2012-10-22

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 sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

Reason for recall

Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

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