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R3 Acetabular 71369776

by Smith & Nephew, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

6 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00885556028698 UDI-DI Date4 May 2015ListedStatusListed GUDID: in commercial distribution

Recalls

6 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-2056-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011
    • Terminated Z-2054-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011
    • Terminated Z-2058-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011
    • Terminated Z-2055-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011
    • Terminated Z-2053-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011
    • Terminated Z-2057-2011 FDA Unclassified (pre-2012) initiated 11 Mar 2011

    During the manufacturing process for several batches of R3 Ceramic Liners, the titanium rings were pressed onto the ceramic component with a higher force than allowed by manufacturing specifications. This has the potential to result in lower than expected strength for the liners.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
R3 Acetabular
Generic Name
Acetabulum prosthesis trial, prefabricated, reusable
Model / Ref / Catalog
71369776
Primary DI / UDI-DI
00885556028698
PMA Number
FDA Product Code
MRA
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable
Device Class
Class III
GUDID distribution status
In Commercial Distribution

Related devices

Category: Acetabulum prosthesis trial, prefabricated, reusable

Cleared under the same submission (P030022)

Show all (12)

Other devices from Smith & Nephew, Inc.

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Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No