FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
- Recall number
- Z-2336-2020
- Recalling firm
- Smith & Nephew, Inc.
- Product
- smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 48MM 71338733 50MM 71338734 52MM 71338735 54MM 71338736 56MM 71338737 58MM 71338738 62MM 71338740 64MM 71338741 Orthopedic implant component.
- Status
- Open, Classified
- Initiated
- 2020-04-22
- Posted
- not on file
- Terminated
- not on file
- Reason
- A manufacturing error resulted in out of specification R3 Acetabular Shells
- Root cause
- Process control
- Action
- The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.
- Quantity
- 58 devices
- Distribution
- Worldwide
- Lot, serial or model codes
- 71338733, Lot Numbers: 19DM28110, 19DM28106, 19DM28106A 71338734, Lot Numbers: 19DM28114 71338735, Lot Numbers: 19DM28116 71338736, Lot Numbers: 19EM19673, 19EM19683, 19EM19678 71338737, Lot Numbers: 18JM12872 71338738, Lot Numbers: 18FM02387 71338740, Lot Numbers: 18JM02713 71338741, Lot Numbers: 19AM22770, 19AM22770A
- 510(k) numbers
- ["K070756"]
- PMA numbers
- not on file
- Product code
- MBL
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28