Uni-polar endo heads recalled over packaging that may compromise sterility
BioPro is recalling 147 metal uni-polar Endo 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 metal uni-polar sizes 38 to 55 are being recalled, covering product numbers 10179 through 10188.
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 (Metal uni-polar, 38-55) Product Number/Description 10179 ENDO MD 38 10180 ENDO MD 41 10181 ENDO MD 43 10182 ENDO MD 45 10183 ENDO MD 47 10184 ENDO MD 49 10185 ENDO MD 51 10186 ENDO MD 53 10187 ENDO MD 55 10188 ENDO SH 38 10189 ENDO SH 41 10190 E
- 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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