Smith & Nephew Recalls R3 Acetabular Shells Due to Manufacturing Error
Smith & Nephew is recalling 4,172 R3 Acetabular Shells distributed worldwide because a manufacturing error resulted in out-of-specification devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a manufacturing defect (out-of-specification) where no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Smith & Nephew, Inc. is recalling 4,172 units of the R3 Three Hole HA Coated Hemispherical Stiktite Coated Shell, an orthopedic implant component. The recall covers devices in sizes ranging from 42mm to 68mm, identified by specific reference numbers and lot numbers.
The recall was initiated because a manufacturing error resulted in out-of-specification R3 Acetabular Shells. The affected devices were distributed worldwide.
Consumers and healthcare providers should stop using the affected devices and contact Smith & Nephew for further instructions.
The recalled product
- Product
- smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71331942 46MM 71331946 48MM 71331948 50MM 71331950 52MM 71331952 54MM 71331954 56MM 71331956 58MM 71331958 60MM 71331960 62MM 713
- Manufacturer
- Smith & Nephew, Inc.
- Affected units
- 4,172
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 71331942
- Lot Numbers: 18HM20692
- 18EM07919 71331946
- Lot Numbers: 18GM07650
- 18GM18522
- 18JM01361
- 18JM14484
- 19DM17868
- 19DM17872
- 19EM20020
- 18GM18521
- 18JM14573
- 19DM10929
- 19DM10931
- 19DM17866
- 19DM17869
- 19DM17871
- 19EM20018 71331948
- Lot Numbers: 18GM16878
- 18JM08597
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 6 recalled by Smith & Nephew, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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