The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2070-2023·Announced 2023-07-12

Surgical collagen matrix recall due to endotoxin testing failures

TEI Biosciences is recalling 22,163 units of SurgiMend PRS collagen matrices due to endotoxin testing deficiencies that may have resulted in contaminated products being distributed. No injuries have been reported.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II medical device recall involves potential endotoxin contamination of surgical implants, which poses a risk of infection and adverse reaction at surgical sites. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

TEI Biosciences is recalling 22,163 units of SurgiMend PRS, a collagen-based surgical implant used for soft tissue reconstruction. The recall was initiated due to deficiencies in the company's endotoxin testing procedures for both in-process and finished products. These testing deficiencies may have resulted in products with out-of-specification endotoxin levels being distributed undetected.

Endotoxins are bacterial substances that can trigger immune and inflammatory responses. When present in surgical implants, endotoxin contamination poses a risk of infection and adverse reactions at the surgical site.

The affected product is available in 14 different sizes and was distributed nationwide in the United States. No illnesses or injuries have been reported in connection with this recall.

Healthcare facilities with affected inventory should quarantine remaining product and contact TEI Biosciences for return instructions. Patients and healthcare providers with questions should contact their health department or the FDA.

The recalled product

Product
SurgiMend PRS; Collagen Matrix for Soft Tissue Reconstruction; Rx Only; Sizes 10x15 cm Semi-Oval, 7x17 cm Fenestrated, 10x20 cm Fenestrated, 8x16 cm Semi-Oval, 15x15 cm Semi-Oval, 8x20 cm Fenestrated, 10x15 cm Slant Fenestrated, 7x17 cm Semi-Oval, 8x16 cm Thin Semi-Oval, 10x20…
Manufacturer
TEI Biosciences, Inc.
Category
Medical Device — Surgical Implant / Tissue Reconstruction
Hazard
Affected units
22,163

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Item No. (UDI-DI): 606-004-100 (10381780112822)
  • 606-004-101 (10381780112839)
  • 606-004-102 (10381780112846)
  • 606-004-103 (10381780112853)
  • 606-004-104 (10381780112860)
  • 606-004-105 (10381780112877)
  • 606-004-106 (10381780112884)
  • 606-004-107 (10381780112891)
  • 606-004-108 (10381780112907)
  • 606-004-109 (10381780112914)
  • 606-004-110 (10381780112921)
  • 606-005-001 (10381780112938)
  • 606-005-002 (10381780112945)
  • 606-007-001 (10381780357322).

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by TEI Biosciences, Inc. 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 17 products in this recall →

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