12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith
FDA device recall Z-2427-2012 · posted 2012-09-20 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Modular necks were manufactured out of specification by a vendor; the taper provide is undersized.
- Action taken
- Smith & Nephew sent an "URGENT:CLASS II RECALL-HIGH OFFSET MODULAR NECK R1213 letter dated August 22, 2012 to all affected customers. The letter identified the product, problem, and the actions to be taken by the customers. Customers were instructed to cease use and distribution of the product and quarantine for return. An Inventory Return Certification Form was included for customers to complete and return via fax to 901-566-7975.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- MEH
- Quantity affected
- 70 units
- Distribution
- Worldwide Distribution-USA (nationwide) including the states of CA, FL, GA, IL, IN, MA, NC, NJ, NY, OH, OK, PA, TN, TX, and WA, and the country of Canada.
- Date initiated
- 2012-08-22
- Date posted
- 2012-09-20
- Date terminated
- 2013-02-27
- Location
- Memphis, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MDF REVISION HIP SYSTEM (K081124) | Smith & Nephew, Inc. | 2008-07-31 |