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R3(Tm) 28 Mm I.D., 60 Mm O.D. Constrained Liner, Ref… recallZ-1738-2015 · Smith & Nephew, Inc. · initiated May 6, 2015

Class II Terminated All recalls posted in June 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Smith & Nephew, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process change control

What the company is doing

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.

Recall details

Recall number
Z-1738-2015
Recall class
Class II
Status
Terminated
Initiated by the company
May 6, 2015
Posted by the FDA
Jun 9, 2015
Recalling firm
Smith & Nephew, Inc.
Quantity
40 units
Product code
KWZ
FDA submissions
K083566
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

Product description

R3(TM) 28 MM I.D., 60 MM O.D. CONSTRAINED LINER, REF 71339160, 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.

Code information (models, lots, serial numbers)

Lot numbers: 16HM08087, 14HM08097, 14HM08133, 14HM08141, and 14JM21517

Other devices under the same FDA submission

8 devices cleared under K083566 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 71330).

Sources and updates

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