Spine Surgery Instrument Sets Recalled for Sterilization Defect
American Contract Systems is recalling ACS Spine Pack and ACS Lumbar/Back Set Up Tray surgical instrument sets due to improper sterilization with excess ethylene oxide. The affected sets were distributed in Illinois, Missouri, Nebraska, and Texas.
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: This is a sterilization process defect affecting surgical instruments. Although no illnesses or injuries have been reported, improper sterilization of medical devices used in spinal procedures represents a risk-of-harm product, meeting the criterion for High (Score 3) severity.
Plain-English summary
American Contract Systems, Inc. is recalling the ACS Spine Pack (Model LOSP35D, Lot 966221) and ACS Lumbar/Back Set Up Tray (Model SALB85AG, Lot 973221). These sterilized surgical instrument sets are designed for spinal procedures and were distributed in Illinois, Missouri, Nebraska, and Texas.
The products were sterilized using an ethylene oxide concentration higher than the specified sterilization parameters. This process deviation may compromise the safety of the surgical instruments.
The recall affects 72 total packs. Healthcare providers who have received these products should stop using them and contact American Contract Systems for instructions on handling the affected sets. Patients who may have been treated with instruments from these lots should consult their healthcare provider if they have concerns.
The recalled product
- Product
- 1) ACS Spine Pack 2) ACS Lumbar/Back Set Up Tray
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- Affected units
- 72
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 (5)
- 1) ACS Spine Pack - Model LOSP35D
- Lot 966221
- UDI 00191072154613 2) ACS Lumbar/Back Set Up Tray - Model SALB85AG
- Lot 973221
- UDI: 00191072127280
Distribution
Part of a larger recall action
This product is one of 5 recalled by American Contract Systems, 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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