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PuraForce™

ORGANOGENESIS INC. · Model 550-006 · UDI-DI 00618474000220

KGN Prescription

510(k) clearances

187

Adverse events (1 deaths)

Recalls

140

Facilities

Description

PuraForce ™ tendon reinforcement matrix is a resorbable collagen based material intended for implantation to reinforce soft tissue. The device is supplied sterile in double layer peel-open packaging. The product is packaged hydrated and is ready to use. PuraForce ™ is intended for reinforcement of soft tissues repaired by sutures or suture anchors, during tendon repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps or other tendons. PuraForce ™ is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps and quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide biomechanical strength for the tendon repair. PuraForce reinforces soft tissue and provides a resorbable scaffold that is replaced by the patient’s own soft tissue.

Recalls

Date	Firm	Reason
2026-03-19	Integra LifeSciences Corp. (NeuroSciences)	Increased rate of out-of-specification endotoxin results.
2026-03-19	Integra LifeSciences Corp. (NeuroSciences)	Increased rate of out-of-specification endotoxin results.
2026-03-19	Integra LifeSciences Corp. (NeuroSciences)	Increased rate of out-of-specification endotoxin results.
2026-03-19	Integra LifeSciences Corp. (NeuroSciences)	Increased rate of out-of-specification endotoxin results.
2026-03-19	Integra LifeSciences Corp. (NeuroSciences)	Increased rate of out-of-specification endotoxin results.
2026-02-10	Medline Industries, LP	Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic
2023-05-23	TEI Biosciences, Inc.	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
2023-05-23	TEI Biosciences, Inc.	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
2023-05-23	TEI Biosciences, Inc.	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
2023-05-23	TEI Biosciences, Inc.	Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.