Integra Mozaik Strip Recalled for Incorrect Instructions for Use Translation
Integra LifeSciences Corp. is recalling Integra Mozaik Strip units because the Instructions for Use contain incorrect Spanish and French translations of the term "bone marrow aspirate."
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to a documentation and translation error in the Instructions for Use, which falls under the 'Low' severity criteria for packaging or documentation-only problems without reported harm.
Plain-English summary
Integra LifeSciences Corp. is recalling 22 units of Integra Mozaik Strip, a bone graft substitute composed of collagen and ceramic matrix. The product is intended for use as a bone void filler in the skeletal system. The recall is limited to specific batch numbers: 105BR0215955 and 105BR0216149.
The reason for the recall is that the Instructions for Use (IFU) for the CE marked Mozaik Strip and Putty products contain an incorrect translation of the term "bone marrow aspirate" in Spanish and French. This is a documentation and labeling issue affecting the accuracy of the provided instructions.
The affected products were distributed worldwide. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for further instructions or replacement.
The recalled product
- Product
- Integra Mozaik Strip 10 cc Product Usage: The product is a bone graft substitute composed of collagen (Type 1) and ceramic (I3-Tricalcium phosphate) matrix in putty and strip forms. The product is intended for use as a bone void filler to fill voids or gaps of the…
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 22
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Integra LifeSciences Corp. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateIntegra Recalls Accell Evo3C Bone Matrix Due to Packaging Error
FDA (Devices) · 2014-07-02
- ModerateSkeletal Kinetics Recalls OsteoVation Bone Filler Kits Due to Labeling Discrepancy
FDA (Devices) · 2021-01-27
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- ModerateIntegra LifeSciences Recalls Cadence Tibial Tray Implant Due to Labeling Error
FDA (Devices) · 2016-07-06
- ModerateGIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use
FDA (Devices) · 2020-02-05
- ModerateIntegra Tibial Total Ankle Prosthesis Tray Recalled for Labeling Error
FDA (Devices) · 2019-04-24