smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Reported: June 17, 2020 Initiated: April 22, 2020 #Z-2331-2020
Product Description
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.
Reason for Recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Details
- Recalling Firm
- Smith & Nephew, Inc.
- Units Affected
- 1267 devices
- Distribution
- Worldwide
- Location
- Memphis, TN
Frequently Asked Questions
What product was recalled? ▼
smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331842 48MM 71331848 50MM 71331850 52MM 71331852 54MM 71331854 56MM 71331856 58MM 71331858 60MM 71331860 Orthopedic implant component.. Recalled by Smith & Nephew, Inc.. Units affected: 1267 devices.
Why was this product recalled? ▼
A manufacturing error resulted in out of specification R3 Acetabular Shells
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on June 17, 2020. Severity: Moderate. Recall number: Z-2331-2020.
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