Segmental Stem, Canal Filling, Straight 120MM recalled for seal breach
Onkos Surgical is recalling segmental stems used in the ELEOS LIMB SALVAGE SYSTEM due to potential breach of Tyvek seals. The breach could compromise the sterility of the medical device.
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: This is a Class II medical device recall involving a potential sterility breach—a high-risk condition in implantable orthopedic devices. The source text identifies a risk of harm (loss of sterile barrier) without reported illnesses or injuries, meeting the High severity criterion.
Plain-English summary
Onkos Surgical, Inc. is recalling 120 units of Segmental Stem, Canal Filling, Straight, 120MM (model numbers FS-11120-03M through FS-21120-03M), which are components of the ELEOS LIMB SALVAGE SYSTEM. The recall was initiated due to potential breach of Tyvek seals on the recalled units.
A breach in the Tyvek seals could compromise the sterile barrier of the medical device, potentially affecting the sterility of the product when it reaches the end user or at the point of use.
The product was distributed from Onkos' facility in Olive Branch, Mississippi to consignees in the following states: Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii. Specific lot numbers are available from the manufacturer and the FDA.
Patients or healthcare providers who have received this product should contact Onkos Surgical, Inc. for instructions on return or replacement. Healthcare facilities should review their inventory and follow appropriate procedures for handling potentially compromised sterile devices.
The recalled product
- Product
- Segmental Stem, Canal Filling, Straight, 120MM, 1 EACH. Model Numbers: FS-11120-03M, FS-12120-03M, FS-13120-03M, FS-14120-03M, FS-15120-03M, FS-16120-03M, FS-17120-03M, FS-18120-03M, FS-19120-03M, FS-20120-03M, FS-21120-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Affected units
- 120
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 (20)
- a. Model Number: FS-11120-03M
- UDI-DI: B278FS1112003M0
- Lot Numbers: 1880532
- 1880533
- 1880534
- 1880535
- 1880536
- 1880537
- 1880538
- 1880539
- 1880540
- 1880541
- 1880542
- 1880543. b. Model Number: FS-12120-03M
- UDI-DI: B278FS1212003M0
- Lot Numbers: 1880544
- 1880545
- 1880546
- 1880547
- 1880548
Distribution
Part of a larger recall action
This product is one of 6 recalled by Onkos Surgical, 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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