Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Class I - DangerousWhat Should You Do?
- Check if you have this product: UDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950106, 48950110, 48950116,48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090,48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126,48951130, 48951136,48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130,48952140,48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076,48954086, 48954096,48954106,48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132,48956086,48956096,48956106, 48956116, 48956126,48956136, 48956146,48956140,48957092,48957112, 48957132, 48956112, 48956132, 48952092,48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076,48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Howmedica Osteonics Corp.
- Reason for Recall:
- The surgical technique is being updated to caution against misuse due to reports of cage fractures occurring intra-operatively and post-operatively.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Tritanium Posterior Lumbar (PL) cage intervertebral body fusion implant. Intended for an open, less invasive, and minimally invasive PLIF or TLIF surgical procedure.
Product Codes/Lot Numbers:
UDI: 07613327117943, All lots, Model Numbers 48950070, 48950076, 48950080, 48950086, 48950090,48950096, 48950100, 48950106, 48950110, 48950116,48950120, 48950126, 48950130, 48950136, 48950140, 48950146, 48951070, 48951076, 48951080, 48951086, 48951090,48951096, 48951100, 48951106, 48951110, 48951116, 48951120, 48951126,48951130, 48951136,48951140, 48951146, 48952070, 48952080, 48952090, 48952100, 48952110, 48952120, 48952130,48952140,48953070, 48953080, 48953090, 48953100, 48953110, 48953120, 48953130, 48953140, 48954076,48954086, 48954096,48954106,48954116, 48954126, 48954136, 48954146, 48955076, 48955086, 48955096, 48955106, 48955116, 48955126, 48955136, 48955146, Vl/48950090, Vl/48953090, Vl/48955096, 48950066, 48954066, 48951092, 48951112, 48951132, 48950092, 48950112, 48950132,48956086,48956096,48956106, 48956116, 48956126,48956136, 48956146,48956140,48957092,48957112, 48957132, 48956112, 48956132, 48952092,48952112, 48952132, 48953092, 48953112, 48953132, 48950102, 48950122, 48950142, 48951102, 48951122, 48951142, 48956076,48956092, 48956102, 48956122, 48956142, 48953102, 48953122, 48953142
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0605-2019
Related Recalls
1. EXETER V40 STEM 44MM NO 2, Model/Catalog Number: 0580-1-442; 2. EXETER V40 STEM 37.5MM NO 0, Model/Catalog Number: 0580-1-352;
Howmedica Osteonics
a potential product mix where the package labeled as Catalog Number 0580-1-442, lot A00976, may contain Catalog Number 0580-1-352, lot G8754849, and vice versa. Patient labels may also be impacted.
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
Howmedica Osteonics
Stryker has identified an issue with the characterization process that impacted the constant values assigned to the associated MICS Handpieces.
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.