Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1053-2022 — 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].

U.S. FDA — Device Enforcement · United States · 2022-03-24 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1053-2022
Date of alert: 2022-03-24
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Ethicon, Inc.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 10705031228054

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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1053-2022 — 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].

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