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Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b)...

FDA Device Recall #Z-1328-2023 — Class II — February 8, 2023

Recall Summary

Recall Number Z-1328-2023
Classification Class II — Moderate risk
Date Initiated February 8, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Medtronic Sofamor Danek USA Inc
Location Memphis, TN
Product Type Devices
Quantity 23850 units

Product Description

Medtronic Grafton Matrix Strips: a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275; d) DBM T42275AUS 8MMX1CMX10CM 2 EA GRFTON S, REF T42275AUS; e) DBM T42275INT 8MMX1CMX10CM 2 EA GRFTON S, REF T42275INT; f) DBM T42275JPN GRAFTON MATRIX 1CM X 10CM, REF T42275JPN; g) DBM T42280 8MMX1CMX20CM 2 EACH GRAFTON M, REF T42280; h) DBM T42280AUS 8MMX1CMX20CM 2 EA GRFTON S, REF T42280AUS; i) DBM T42280INT 8MMX1CMX20CM 2 EA GRFTON S, REF T42280INT; j) DBM T42280JPN GRAFTON MATRIX 1CM X 20CM, REF T42280JPN; Demineralized Bone Matrix (DBM) product

Reason for Recall

Potential for packaging non-conformances directly related to the dual-barrier, sterile pouch packaging system. Non-conforming packaging may lead to a breach in the sterile barrier.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Australia, Austria, Brunei Darussalam, Canada, Chile, Colombia, Denmark, Dominican Republic, Ecuador, Finland, Ghana, Greece, Guatemala, Hong Kong, India, Ireland, Israel, Jamaica, Japan, Jordan, Korea, Republic Of, Kuwait, Lebanon, Liechtenstein, Luxembourg, Macao, Malaysia, Mexico, Mongolia, Namibia, Netherlands, New Zealand, Norway, Oman, Panama, Paraguay, Peru, Philippines, Portugal, Puerto Rico, Saudi Arabia, Singapore, South Africa, Spain, Switzerland, Taiwan, Thailand, Trinidad And Tobago, United Arab Emirates, United Kingdom, Viet Nam.

Lot / Code Information

a) DBM S42275 8MMX1CMX10CM 2EA MATRIX STRPS, REF S42275, GTIN 00613994960931, Serial Numbers: A42914, A43126, A43182, A43185, A43460, A43613, A43715, A43896, A44262, A44388, A44561, A45997, A46401, A46690, A46699, A47001, A47719, A47942, A48136, A48371, A48792, A49045, A49089, A49108, A49790, A49952, A50039, A50528, A50688, A51827, A52539, A52601, A52788, A53401, A53671, A53788, A53881, A53904, A54204, A54988, A55032, A55132; b) DBM S42280 8MMX1CMX20CM 2EA MATRX STRPS, REF S42280, GTIN 00613994960924, Serial Numbers: A42850, A43731, A44343, A44529, A44821, A45022, A45035, A46734, A47604, A47621, A47701, A47971, A48051, A48578, A49616, A51011, A52580, A52809, A54208, A54369, A54440, A54597, A55584; c) DBM T42275 8MMX1CMX10CM 2 EACH GRAFTON M, REF T42275, GTIN 00643169123076, Serial Numbers: A39563-061, A39563-062, A39563-063, A39563-064, A39563-065, A39563-066, A39563-068, A39563-070, A39563-071, A39563-072, A39563-073, A39563-074, A39563-075, A39563-076, A39563-077, A40837-011, 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Other Recalls from Medtronic Sofamor Danek USA Inc

Recall # Classification Product Date
Z-0580-2026 Class II Catalyft PL & PL40 Expandable Interbody System ... Sep 16, 2025
Z-0162-2024 Class II Grafton DBM (Flex), Model Numbers: T42100, Demi... Sep 26, 2023
Z-0165-2024 Class II Grafton DBM Orthoblend, Model Numbers: a) T4412... Sep 26, 2023
Z-0166-2024 Class II Grafton Plus DBM Paste, Model Numbers: a) T4500... Sep 26, 2023
Z-0167-2024 Class II Grafton DBM Putty, Model Numbers: a) T43102, b)... Sep 26, 2023

Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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