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.
- Affected units
- 147
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
Part of a larger recall action
This product is one of 6 recalled by BioPro, 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.
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