Z-0083-2011

R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1...

Name: Z-0083-2011 R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1...
Creator: Smith & Nephew Inc
Published: 2010-08-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-08-13 / Terminated

FDA source

Smith & Nephew Inc began a recall of R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular... on 2010-08-13. The reason FDA records is "The firm received reports of a femoral head popping out of the liner intraoperatively". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0083-2011
Status: Terminated
Initiated: 2010-08-13
Posted: 2010-10-18
Terminated: 2011-09-21
Recalling firm: Smith & Nephew, Inc.
Product: R3 (TM) 28 MM I.D., 60 MM O.D., CONSTRAINED LINER, UHMWPE, CO-CR, TI-6AL-4V, REF 71339160, STERILE EO, QTY 1, Smith & Nephew, Inc., Hip prosthesis acetabular component. Acetabular Liner
Product code: KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
Reason for recall: The firm received reports of a femoral head popping out of the liner intraoperatively.
FDA root cause: Other
Action: Smith & Nephew notified all distributors via e-mail and sent a letter dated August 13, 2010 to all hospitals notifying them of the product, the problem, and the action to be taken. 1) Distributors were to immediately cease distribution and use of the product, examine their stock and the stock of the accounts they supplied if applicable and remove any affected devices from all inventories and place them into quarantine to prevent accidental distribution. 2) Identify customers that received these products and immediately notify them of the recall. 3) Carry out a physical count and record the data on the Verification Section included in the letter. 4) Contact their inventory specialist for an RA# and record this on the Verification Section. 5) Return the Verfication Section even if they do not have the recalled product. 6) Return the recalled product to: Smith & Nephew, Inc. Attn: Return Goods 3303 Holmes Road Memphis, TN 38118 Smith & Nephew, Inc. sent a second notice via e-mail on 09/03/2010 to non-responding distributors and by Fed Ex to the hospitals 09/21/2010. For any questions regarding this recall customers were to call (901) 399-5441.
Quantity in commerce: 91 units
Distribution: Worlwide Distribution, USA including AL, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, WA, and WI and the countries of Australia and Portugal
Product codes and lots: All lots

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)