Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH
FDA device recall Z-0573-2016 · posted 2016-01-04 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.
- Action taken
- The firm, Smith & Nephew Inc, notified the distributors by Fed- Ex on 10/20/2015 and sent an "Urgent - Product Recall 1st Notification - Urgent R-2015-22" letter dated 11/9/2015 to their customers. The letter described the product, problem, and actions to be taken. The customers were instructed to inspect your inventory and locate any unused devices, quarantine them immediately, complete and return the Inventory Return Certification Form by fax to: +1-901-566-7975 or email to: FieldActions@smith-nephew.com, even if you do not have the product, contact Smith & Nephew's Field Actions Department via email or fax (above) to obtain a return authorization (RA) number, and return any affected product to Smith & Nephew, Attn: Global Field Actions, Global Distribution Center, 3303 E Holmes Road, Memphis, TN 38118. If you have any questions, call Director, Regulatory Affairs 901-399-5520 or email: jason.sells@smith-nephew.com.
- Root cause
- Process design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 20 units
- Distribution
- US Distribution to states of:FL, MO, IN and TX.
- Date initiated
- 2015-11-09
- Date posted
- 2016-01-04
- Date terminated
- 2016-03-17
- Location
- Memphis, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENESIS II TOTAL KNEE SYSTEM (K951987) | Smith & Nephew Richards, Inc. | 1995-08-22 |