Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are
FDA device recall Z-0538-2018 · posted 2018-01-18 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Wrong device description of the label identifying the implant
- Action taken
- Exactech sent an Urgent Medical Device Recall letter dated October 9, 2017, informing them of the potential mislabel. The notice requested consignees: Immediately cease distribution/use of this product; Extend information to accounts in possession of the product; Identify and quarantine any subject devices in their inventory; Complete and return Recall Acknowledgement and Recall Inventory Response Forms. For further questions, please call (800) 392-2832.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 34
- Distribution
- US Distribution to the states of : AL, CA, CO, FL, MD. and NY
- Date initiated
- 2017-10-09
- Date posted
- 2018-01-18
- Date terminated
- 2019-08-06
- Location
- Gainesville, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Exactech® Alteon® HA Femoral Stem (K162732) | Exactech, Inc. | 2017-04-26 |