Customed Ortho-Implant Surgical Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 153 Ortho-Implant Surgical Packs distributed in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
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: The recall involves a risk-of-harm product (sterile surgical packs) where the hazard is theoretical due to inadequate sterilization validation, and no injuries or illnesses have been reported.
Plain-English summary
Customed, Inc. is recalling 153 units of the Ortho-Implant Surgical Pack (Catalog Number 900741A). These products are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products released for distribution as sterile. The affected lots were distributed only in Puerto Rico.
Medical facilities and consumers who have these products should stop using them and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Catalog Number: 900741A ORTHO-IMPLANT SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Affected units
- 153
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 recalled by Customed, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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