Hip bipolar heads recalled over packaging that may compromise sterility
Total Joint Orthopedics is recalling 103 Klassic BiPolar Heads over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: the firm states a compromised sterile barrier presents an infection risk if implanted, and no injuries are reported.
Plain-English summary
Klassic BiPolar Heads from Total Joint Orthopedics are being recalled across catalog numbers including 3205.41.022 (41 mm OD, 22 mm head), 3205.42.022, 3205.43.022 and 3205.44.028.
The firm identifies 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 103 units, including UDIs 00814703011931, 00814703011948 and 00814703011955, distributed in Ohio, Texas, Florida, Georgia and North Carolina. The FDA has classified the action as Class II.
The enforcement record describes the risk and reports no injuries. Facilities should quarantine affected lots and follow the firm's instructions.
The recalled product
- Product
- Brand Name: Klassic BiPolar Head Model/Catalog Number: 3205.41.022 Klassic BiPolar Head, 41 mm OD, 22 mm Head; 3205.42.022 Klassic BiPolar Head, 42 mm OD, 22 mm Head; 3205.43.022 Klassic BiPolar Head, 43 mm OD, 22 mm Head; 3205.44.028 Klassic BiPolar Head, 44 mm OD, 28…
- Manufacturer
- Total Joint Orthopedics, Inc.
- Affected units
- 103
Distribution
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