Customed Orthopedic Implants Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 81 orthopedic implants 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 is classified as FDA Class II and involves a risk-of-harm product (sterile implant) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 81 units of orthopedic implants (IMPLANTE DE ORTHOPEDIA 3/CS) used by medical staff for surgical procedures and patient care. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The recall includes specific lot numbers 141015721, 141015605, and 141216407, with expiration dates ranging from October 31, 2015, to December 31, 2015.
Medical facilities and consumers should stop using these specific lots of orthopedic implants and contact Customed, Inc. for further instructions or returns.
The recalled product
- Product
- IMPLANTE DE ORTHOPEDIA 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Affected units
- 81
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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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