R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, QTY: (1), STERILE EO, Product Usage: The R3 Constrained l
FDA device recall Z-1738-2015 · posted 2015-06-09 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- Reason for recall
- The R3 Constrained outer liner locking groove diameter is 0.030 inches oversized and may not allow the locking ring to engage into the R3 shell.
- Action taken
- Smith & Nephew sent an Urgent-Product Recall Notification letter dated May 6, 2015. to Sales offices by E-mail and Hospitals via Fed- Ex. The letter identified the affected product, problem and actions to be taken. Customers were asked to quarantine the product and return it. Distributors were asked to notified their customers of the recall and ask them to return the product.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- KWZ
- Quantity affected
- 40 units
- Distribution
- Worldwide Distribution - US Nationwide in the states of CA, FL, IL, IN, MI, NE, NY, TN, TX, VA, WI and the countries of Australia, Switzerland, Chile, Canada, and Spain
- Date initiated
- 2015-05-06
- Date posted
- 2015-06-09
- Date terminated
- 2022-04-01
- 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 |
|---|---|---|
| R3 CONSTRAINED LINER, CONSTRAINED LINER (K083566) | Smith & Nephew, Inc. | 2009-03-03 |