Restoration HA Reduced Neck 255 mm Long Stem Manufactured by Stryker Howmedica Osteonics Corp. 325 Corporate Drive Mahwa
FDA device recall Z-1677-2012 · posted 2012-05-29 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- An incorrect laser mark was noted on specific lots of product, incorrectly implying a stem size of 9, when the product is actually size 8.
- Action taken
- Stryker sent an "URGENT PRODUCT RECALL" letter dated October 27, 2011 and October 28, 2011 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs the customers to return the product to the firm. An Acknowledgement Form was included for customers to complete and return. Contact the firm at 201-972-2100 for questions regarding this recall.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 31 Units
- Distribution
- Nationwide Distribution and the country of Canada.
- Date initiated
- 2011-10-27
- Date posted
- 2012-05-29
- Date terminated
- 2013-08-22
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| OSTEONICS RESTORATION MONOLITHIC II SLOTTED HIP STEM SERIES (K951671) | Osteonics Corp. | 1995-09-06 |