Device product
R3(TM) 22 MM I.D., 58 MM O.D. CONSTRAINED LINER, REF 71339158, QTY: (1), STERILE EO. Product Usage: The R3 Constrained liner Acetabular System is a cemented or uncemented prosthesis intended to replace a hip joint. The Constrained liner is intended for primary or revision patients at high risk for hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered. The R3 Constrained liner is intended for single use only.
Z-1737-2015
Product summary
- Event
- Event 71330
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12 units
- Official record key
device-enforcement:Z-1737-2015
Official wording
Reason: 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.
Code information: Lot numbers: 14GM08613, 14HM08037
Distribution pattern: 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
Derived failure modes
-
Unknown
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.