The Recall Desk
HighFDA (Devices)·Z-0148-2026·Announced 2025-10-22

Metal and ceramic femoral heads recalled over sterile barrier packaging defect

BioPro is recalling 147 cobalt chromium and ceramic femoral 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 Femoral Heads in cobalt chromium and ceramic, sizes 22, 28, 32, 36 and 40 mm, are being recalled. Affected part IDs include 18593 (22MM -3), 18594 (22MM +0), 19003 (28MM -6), 19004 (28MM -3), 19005 (28MM +0) and 19006.

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 Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD
Manufacturer
BioPro, Inc.
Category
Medical Device — Orthopedic implant
Hazard
  • sterile-barrier-breach
  • packaging-defect
  • infection-risk
  • implant

Distribution

Distribution scope not specified by the agency.

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