The Recall Desk
HighFDA (Devices)·Z-1078-2024·Announced 2024-02-21

Skin Graft Carrier Recalled for Manufacturing Ratio Defect

Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers due to a manufacturing defect where the ridge pattern is 1.5:1 instead of 3:1, potentially causing tissue damage or additional grafting.

What this means for you

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 is an FDA Class II recall with no reported illnesses or injuries. The hazard—potential minor tissue damage or additional surgical procedures—is theoretical rather than documented. It fits the criterion for High severity: risk-of-harm products where injury has not yet been reported.

Plain-English summary

Zimmer Surgical Inc. is recalling 3:1 Dermacarrier skin graft carriers, Model Number 00219501300. These devices are used in surgical procedures to carry skin grafts.

The recall is due to a manufacturing defect. The product is labeled as having a 3:1 ridge ratio but the units produced contain a 1.5:1 ridge ratio instead. According to the manufacturer, this discrepancy may result in minor tissue damage or necessitate additional unplanned graft procedures.

The recall affects 76 boxes (1,520 units) distributed within the United States across multiple states, and 521 boxes (10,420 units) distributed internationally to Australia, Canada, Hong Kong, India, Japan, Mexico, Netherlands, Korea, Singapore, Taiwan, and Thailand. Affected lot numbers are 65292843 (expires October 16, 2026) and 65390419 (expires January 18, 2027).

The recalled product

Product
3:1 Dermacarrier, Model Number 00219501300, skin graft carrier
Manufacturer
Zimmer Surgical Inc
Category
Medical Device — Surgical / Skin Grafting
Hazard

Distribution

Distributed nationwide across the United States.

The notice also names 26 states specifically:

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