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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Synthes (USA) Products LLC: It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post implantation, which may expose patients to potential risks in the event a surgeon intends to temporarily apply and subsequently remove a SYNTHECEL implant. SYNTHECEL Dura Repair labeling and promotional material are being updated to clarify that SYNTHECEL is intended to remain in place and is not intended to be removed.

Agency Publication Date: October 11, 2018
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Affected Products

Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SYNTHECEL Dura Repair 2.5 cm x 2.5 cm (1x1), part numbers: SC.400.006.01S, Lot Numbers: 7840311, 7855336, 7860563, 7909569, 7922340, 7932410, 7984104

Lot Numbers:
Numbers
Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SYNTHECEL Dura Repair 2.5 cm x 7.5 cm (1x3), part numbers: SC.400.019.01S, Lot Numbers: 7840492, 7855337, 7860565, 7880949, 7901437, 7909570, 7922341

Lot Numbers:
Numbers
Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SYNTHECEL Dura Repair 5.0 cm x 5.0 cm (2x2), part numbers: SC.400.025.01S, Lot Numbers: 7840495, 7855339, 7860566, 7880950, 7900039, 7909573, 7922342, 7932416, 7984107

Lot Numbers:
Numbers
Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SYNTHECEL Dura Repair 7.5 cm x 7.5 cm (3x3), part numbers: SC.400.056.01S, Lot Numbers: 7840501, 7855340, 7860569, 7880951, 7900040, 7909689, 7922343, 7932422, 7937107, 9800722, 9813796, 9862235

Lot Numbers:
Numbers
Product: SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name: Dura Substitute Device listing number: D140596, D211012 SYNTHECEL Dura Repair is intended for use as a dura replacement for the repair of dura mater in adults.

SYNTHECEL Dura Repair 10.0 cm x 12.0 cm (4x5), part numbers: SC.400.120.01S, Lot Numbers: 7840506, 7840507, 7840509, 7855341, 7855342, 7855343, 7855344, 7855345, 7855346, 7855347, 7855349, 7860570, 7880952, 7900041, 7909693, 7922344, 7932423, 7937109, 7984110, 7989071, 9803078, 9810917

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 73559
Status: Resolved
Manufacturer: Synthes (USA) Products LLC
Manufactured In: United States
Units Affected: 5 products (212 units; 200 units; 289 units; 378 units; 317 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.