Device recall: smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product…

Class II FDA enforcement event 85637. Recall start date: 22 Apr 2020. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

A manufacturing error resulted in out of specification R3 Acetabular Shells

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Smith & Nephew, Inc. started this device recall on 22 Apr 2020. The firm address in the FDA record is in Memphis, TN. FDA put the recall in Class II. FDA event 85637 has 6 product records. The first FDA enforcement report date is 17 Jun 2020. The record gives the status Ongoing.

FDA enforcement report The 6 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Worldwide

Recalling firm

Smith & Nephew, Inc., Memphis, TN.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

6 product records in the event.

FDA event 85637: product records
Recall number	Product	Quantity	Class	Status	Report date
Z-2331-2020	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.	1267 devices	Class II	Ongoing	17 Jun 2020
Z-2332-2020	smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 42MM 71332242 46MM 71332246 48MM 71332248 50MM 71332250 52MM 71332252 54MM 71332254 56MM 71332256 58MM 71332258 60MM 71332260 62MM 71332262 64MM 71332264 Orthopedic implant component.	1450 devices	Class II	Ongoing	17 Jun 2020
Z-2333-2020	smith&nephew R3 THREE HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Size REF/product number 40MM 71335540 42MM 71335542 44MM 71335544 46MM 71335546 48MM 71335548 50MM 71335550 52MM 71335552 54MM 71335554 56MM 71335556 58MM 71335558 60MM 71335560 Orthopedic implant component.	6468 devices	Class II	Ongoing	17 Jun 2020
Z-2334-2020	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 71331962 64MM 71331964 68MM 71331968 Orthopedic…	4172 devices	Class II	Ongoing	17 Jun 2020
Z-2335-2020	smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the following sizes: Sizes REF/product number 48MM 71338663 50MM 71338664 52MM 71338665 54MM 71338666 56MM 71338667 58MM 71338668 Orthopedic implant component.	1766 devices	Class II	Ongoing	17 Jun 2020
Z-2336-2020	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.	58 devices	Class II	Ongoing	17 Jun 2020

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Device events that started in 2020: 916
Share of these events in Class II: 93%
Product records in this event: 6Median of the firm: 1
Events of the firm on the register: 107

Other events of the firm

Other FDA enforcement events of Smith & Nephew, Inc.
Initiated	Product (first record)	Type	Class	Records
16 Mar 2026	TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816	Device	Class II	1
24 Nov 2025	BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.	Device	Class II	1
18 Mar 2025	META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690	Device	Class II	1
29 Oct 2024	BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.	Device	Class II	1
15 Oct 2024	Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femo	Device	Class II	1
2 Oct 2024	smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELL	Device	Class II	2
2 Oct 2024	smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT, SIZE 5 LEFT, REF 71421015; Uncoated knee femur	Device	Class II	2
12 Aug 2024	ROTATION MEDICAL TENDON STAPLES (8) (broad indication)-Intended for fixation of prosthetic material to soft tissues. Pro	Device	Class II	2
9 Jul 2024	DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener	Device	Class II	2
24 Apr 2024	smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71	Device	Class II	1

Smith & Nephew, Inc.: all 107 events

Official channels

FDA enforcement report Z-2331-2020The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 85637. https://recallregister.com/fda/ii/85637/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA device enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Worldwide
What quantity of product is in FDA event 85637?: The event has 6 product records. The first record gives this quantity: 1267 devices
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many device recalls of 2020 have the same class?: 93% of the 916 device events that started in 2020 are in Class II.