The Recall Desk
HighFDA (Devices)·Z-0152-2026·Announced 2025-10-22

Ceramic endo modular heads recalled over sterile barrier packaging defect

BioPro is recalling 147 ceramic Endo Modular Heads over a potential packaging issue that could compromise the sterile barrier and risk infection if implanted.

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: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on an implant creates an infection risk, and no injuries are reported.

Plain-English summary

BioPro Endo Heads in ceramic are being recalled, covering product IDs 13006 (Endo Modular Ceramic SH 38), 13012 (SH 51), 13013 (MD 38), 13019 (MD 51), 13007 (SH 41) and 13008.

There is a potential packaging issue that could compromise the sterile barrier. The defect may result in loss of sterility of the device, presenting a potential risk of infection if the device is implanted.

The recall covers 147 units, distributed to Texas and Michigan. The FDA has classified the action as Class II.

The enforcement record describes the packaging issue and reports no injuries. Facilities should quarantine affected stock and follow BioPro's instructions.

The recalled product

Product
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CER
Manufacturer
BioPro, Inc.
Category
Medical Device — Orthopedic implant
Hazard
  • sterile-barrier-breach
  • packaging-defect
  • infection-risk
  • implant

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 (1)

  • all serial numbers

Distribution

Distribution scope not specified by the agency.

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