—#137318

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.

FDA product code: KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K083566
Affected lot / code info: Lot numbers: 14GM08613, 14HM08037

Why it was recalled

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.

Root cause (FDA determination)

Process change control

Action the firm took

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.

Recalling firm

Firm: Smith & Nephew, Inc.
Address: 1450 E Brooks Rd, Memphis, Tennessee 38116-1804

Distribution

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

Timeline

Recall initiated: 2015-05-06
Posted by FDA: 2015-06-09
Terminated: 2022-04-01
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137318. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.