Customed Inc Recalls Sterile Hip and Knee Replacement Surgical Kits
Customed, Inc. is recalling 39 sterile hip and knee replacement kits distributed in Puerto Rico due to inadequate sterilization validation and package integrity issues.
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 is classified as FDA Class II and involves a risk-of-harm product (sterile surgical kits) where the hazard is theoretical (inadequate sterilization) and no injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 39 units of sterile hip and knee replacement kits. These products are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation. The recall was initiated because of inadequate validation and qualification of sterilization processes and package integrity for products released for distribution as sterile.
The affected products were distributed only in Puerto Rico. The specific lot numbers involved are 141015727 (expiration date 6/30/15) and 150116555 (expiration date 1/31/16), with code 9002614. The agency has classified this recall as Class II.
Healthcare facilities and consumers who have these specific sterile kits should stop using them and contact the recalling firm for further instructions. The recall addresses the risk that the products may not be sterile as intended due to the identified process and packaging deficiencies.
The recalled product
- Product
- HIP AND KNEE REPLACEMENT 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
- Category
- Medical Device — Surgical Kits
- Affected units
- 39
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 (1)
- Code:9002614 Lots: 141015727 exp. 6/30/15 150116555 exp. 1/31/16
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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