The Recall Desk
HighFDA (Devices)·Z-0524-2023·Announced 2022-12-21

Stradis Healthcare Surgical Knee Packs Recalled for Incomplete Sealing

HENRY SCHEIN Knee Packs are being recalled due to incomplete outer bag sealing that may breach sterility. Affected surgical kits were distributed in the US and Canada.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall involving a sterility breach in surgical procedure kits. Although no illnesses have been reported, the incomplete sealing presents a theoretical risk of contamination during medical procedures, which meets the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Stradis Medical, LLC, doing business as Stradis Healthcare, is recalling HENRY SCHEIN Knee Packs (Item No. 570-2908). Medical and surgical procedure kits in this recall underwent certain manufacturing conditions that resulted in incompletely sealed outer bags.

The incomplete sealing may result in a breach in the sterility of the kit. The recalled kits were distributed nationwide in the United States and Canada, with lot number 22241489773.

Compromised sterility in surgical procedure kits creates a risk of contamination during medical and surgical procedures. Healthcare facilities should verify whether they have received affected units.

The recalled product

Product
HENRY SCHEIN, Knee Pack, Item No.570-2908,
Manufacturer
Stradis Medical, LLC dba Stradis Healthcare
Category
Medical Device — Surgical Kit
Hazard
  • sterility-breach
  • contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • UDI/DI (case) H65857029081
  • UDI/DI (kit)M75257029080
  • Serial/Lot Numbers: 22241489773

Distribution

Distributed nationwide across the United States.

Related recalls

Same category