Orthopedic Stem Component Recalled for Potential Packaging Seal Defects
Onkos Surgical is recalling 77 segmental stem components used in its ELEOS limb salvage system due to potential breaches in Tyvek seals. Affected units were distributed to hospitals in 18 states.
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 for a surgical implant component due to potential packaging seal defects. While no illnesses or injuries have been reported, the potential for seal breach on a sterile surgical product that will be implanted in patients poses a risk of harm. Per the rubric, recalls involving risk-of-harm products without reported injury fall into the High category.
Plain-English summary
Onkos Surgical is recalling 77 units of the Segmental Stem, Canal Filling, Bowed 152MM component, which is part of the ELEOS Limb Salvage System. The recall affects 11 model numbers (FB-11152-03M through FB-21152-03M), each with specific lot numbers identified in the recall notice.
The recall is due to the potential for breach of Tyvek seals on the affected products.
The affected products were distributed from Onkos' facility in Olive Branch, Mississippi to healthcare facilities in 18 U.S. states: Georgia, Texas, Washington, Louisiana, New Jersey, Florida, Arizona, Maryland, Mississippi, Kansas, Illinois, Wisconsin, Kentucky, Pennsylvania, North Carolina, Nebraska, Ohio, and Hawaii.
Healthcare facilities that may have received affected products should contact Onkos Surgical for specific lot information and guidance.
The recalled product
- Product
- Segmental Stem, Canal Filling, Bowed 152MM, 1 EACH. Model Numbers: FB-11152-03M, FB-12152-03M, FB-13152-03M, FB-14152-03M, FB-15152-03M, FB-16152-03M, FB-17152-03M, FB-18152-03M, FB-19152-03M, FB-20152-03M, FB-21152-03M. Component of ELEOS LIMB SALVAGE SYSTEM
- Manufacturer
- Onkos Surgical, Inc.
- Hazard
- seal-breach
- contamination-risk
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: FB-11152-03M
- UDI-DI: B278FB1115203M0
- Lot Numbers: 1880455
- 1880456
- 1880457
- 1880458
- 1880459
- 1880460
- 1880461
- 1880462
- 1880463. b. Model Number: FB-12152-03M
- UDI-DI: B278FB1215203M0
- Lot Numbers: 1880464
- 1880465
- 1880466
- 1880467
- 1880468
- 1880469. c. Model Number: FB-13152-03M
- UDI-DI: B278FB1315203M0
- Lot Numbers: 1880470
Distribution
Distributed in 18 states:
- AZ
- FL
- GA
- HI
- IL
- KS
- KY
- LA
- MD
- MS
- NC
- NE
- NJ
- OH
- PA
- TX
- WA
- WI
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