Z-1738-2015Class II

R3(tm) 28 Mm I.d., 60 Mm O.d. Constrained Liner, Ref 71339160, Qty: (1), Sterile Eo

Name: Z-1738-2015 R3(tm) 28 Mm I.d., 60 Mm O.d. Constrained Liner, Ref 71339160, Qty: (1), Sterile Eo
Creator: Smith & Nephew, Inc.
Published: 2015-05-06
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2015-05-06 / Terminated

FDA source

Smith & Nephew, Inc. began a recall of 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... on 2015-05-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1738-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-06
Posted: 2015-06-09
Terminated: 2022-04-01
Recalling firm: Smith & Nephew, Inc.
Product: 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.
Product code: KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
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.
FDA root cause: Process change control
Action: 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.
Quantity in commerce: 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
Product codes and lots: Lot numbers: 16HM08087, 14HM08097, 14HM08133, 14HM08141, and 14JM21517

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1738-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1735-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1736-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1737-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1738-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09
Z-1739-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-17	2015-06-09

Product code KWZ

K083566Class IIR3 Constrained Liner, Constrained LinerSmith & Nephew, Inc. / cleared 2009-03-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)