Customed Medical Device Recall for Sterilization Validation Deficiencies
Customed, Inc. is recalling 210 units of knee and hip replacement devices distributed in Puerto Rico due to inadequate sterilization validation and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 high-risk medical device with a potential sterility failure, but the source text explicitly states no illnesses or injuries have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Customed, Inc. is recalling 210 units of knee and hip replacement devices (Code 9002726) that were distributed exclusively in Puerto Rico. The recall was initiated because the manufacturer identified inadequate validation and qualification of the sterilization processes, as well as issues with package integrity for products released for distribution as sterile.
The affected lots include 141015706, 141216325, 150116528, 150117019, 150317948, 150317949, and 150518787, with expiration dates ranging from October 31, 2015, to May 31, 2016. These devices are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The source text does not report any illnesses or injuries associated with these devices. Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the devices and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- REEMPLAZO DE RODILLA Y CADERA 2/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
- 210
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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