GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic
FDA device recall Z-0131-2014 · posted 2013-11-01 · Terminated
Recall details
- Recalling firm
- Smith & Nephew Inc
- Reason for recall
- Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa.
- Action taken
- Smith & Nephew sent an Urgent - Product Recall 1st Notification letter to all affected sales staff via email and FedEx on October 7, 2013. The hospital was notified by sales rep on October 9, 2013 and the notification letter was sent to the hospital via Fed Ex on October 11, 2013. The letter identified the affected product, problem and actions to be taken. Customers were instructed to inspect inventory, discontinue use, quarantine affected products immediately and return to Smith & Nephew. Customers were asked to complete the attached Inventory Return Certification Form and fax to 901-566-7975.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 4 units
- Distribution
- USA Nationwide Distribution in the states of: AZ, NC, IA, PA, OH, MD, and TN.
- Date initiated
- 2013-10-07
- Date posted
- 2013-11-01
- Date terminated
- 2016-08-23
- 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 |