Integra Recalls NewPort MIS Rod 2 Due to Potential Misalignment
Integra LifeSciences is recalling 94 units of NewPort MIS Rod 2 because the rods may be offset from specifications, potentially causing misalignment during surgical insertion.
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 the hazard involves a risk of harm (misalignment during surgery) where specific injuries or illnesses have not yet been reported in the source text.
Plain-English summary
Integra LifeSciences Corp. is recalling 94 units of the NewPort System MIS Rod 2. The affected product is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws. The recall covers specific model numbers ranging from 45mm to 80mm, including 60-0545, 60-0550, 60-0555, 60-0560, 60-0575, and 60-0580.
The recall was initiated because the rods may be up to 30 degrees offset from specification requirements. This deviation could cause misalignment with the inserter, potentially resulting in the lordosis of the rod not aligning with the handle when the inserter is used according to the current NewPort MIS System Surgical Technique.
The affected units were distributed worldwide, including in the United States (California, Florida, Illinois, Maryland, Missouri, Tennessee, and Texas) and in Australia, the Czech Republic, and Spain. Specific lot numbers include Z21781A, Z21956A, Z21782A, Z21957A, Z21784A, and Z21958A. Healthcare providers and patients should contact the manufacturer or their supplier for further instructions regarding the replacement or return of these devices.
The recalled product
- Product
- MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60-0555 (55mm); 60-0560 (60mm); 60-0575 (75mm); 60-0580 (80mm). The NewPort MIS Rod 2 is a 5.5 diameter titanium spinal rod used to immobilize adjacent NewPort pedicle screws
- Manufacturer
- Integra LifeSciences Corp.
- Category
- Medical Device — Spinal Implant
- Affected units
- 94
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 (7)
- Lot No. Z21781A (45mm NewPort MIS Rod
- 2) Z21956A (50mm NewPort MIS Rod
- 2) Z21782A (55mm NewPort MIS Rod
- 2) Z21957A (60mm NewPort MIS Rod
- 2) Z21784A (75mm NewPort MIS Rod
- 2) Z21958A (80mm NewPort MIS Rod
- 2)
Distribution
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