Medline Lumbar Delivery System Recalled Due to Sterilization Failure
Medline Industries is recalling 122 units of HOI Lumbar Complete Delivery Systems because the sterile packs did not complete a sterilization cycle, compromising sterility.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. The failure to complete a sterilization cycle for a surgical implant presents a significant risk of infection or serious injury, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries Inc is recalling 122 units of the HOI Lumbar Complete Delivery System (Reference DYNJ902823G, Lot 20AKA895). The recall was initiated because the sterile pack inside the system did not go through a complete sterilization cycle. As a result, the sterility of these components cannot be guaranteed.
The affected products were distributed only in California to three facilities: Torrance Memorial Medical Center, Hoag Memorial Hospital, and Owens/Minor VMI. The recall number is Z-1357-2020, and the products have an expiration date of May 31, 2021.
Healthcare facilities should stop using these specific units and contact Medline Industries for further instructions on return or disposal. Patients who have already received these implants should contact their healthcare provider for guidance.
The recalled product
- Product
- Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180
- Manufacturer
- Medline Industries Inc
- Affected units
- 122
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Medline Industries 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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