Bipolar femoral heads recalled over packaging that may compromise sterility
BioPro is recalling 147 bipolar 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 Bipolar Heads are being recalled, covering product IDs 18130 through 18137 in sizes 38 mm to 45 mm.
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 Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BI
- Manufacturer
- BioPro, Inc.
- 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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