smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL
Medical device recall Z-2332-2020. Published in FDA’s Enforcement Report on Jun 17, 2020.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Jun 17, 2020. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 1450 devices how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
71332242, Lot Numbers: 18HM20693, 18HM20693A 71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A 71332248, Lot Numbers: 18MM01856, 19BM08386, 19DM17884, 19DM17885, 19DM17890, 19EM11946, 19EM11947, 19DM17881, 18GM04752, 18GM04753,…
Every code shown here, 1,998 characters
71332242, Lot Numbers: 18HM20693, 18HM20693A 71332246, Lot Numbers: 19EM17729, 19EM17730, 19EM17730A 71332248, Lot Numbers: 18MM01856, 19BM08386, 19DM17884, 19DM17885, 19DM17890, 19EM11946, 19EM11947, 19DM17881, 18GM04752, 18GM04753, 18HM00807 71332250, Lot Numbers: 18JM05436, 18JM05435, 18JM05436, 19BM17964, 19DM06430, 19DM06500, 19EM03960, 18FM17594, 18GM01199, 18EM13916, 18EM13934, 18JM12796, 18JM12800, 19BM17961, 19CM15771, 19EM03956, 19EM03970, 18EM13916A, 18EM13916B, 18FM00218 71332252, Lot Numbers: 18FM02450, 18FM11167, 18GM09577, 18HM15279, 18HM15304, 18HM23477, 18HM23481, 18JM12802, 18JM12811, 18KM03172, 18LM10404, 18LM10407, 19DM21921, 19DM21927, 19EM09563, 19EM09574, 18FM01063, 18GM01228, 18GM04749, 18GM06567, 18GM17030, 18EM06114, 18EM06116, 18FM01038, 18FM00235, 18MM02061, 18MM05779, 19DM21920, 19DM21922, 19DM21925, 19DM21920A 71332254, Lot Numbers: 18FM02451, 18GM16977, 18HM15323, 18JM08634, 18JM08635, 18JM08636, 18LM10411, 18LM10411A, 18LM10411B, 18LM10414, 18MM10067, 18MM10067A, 18MM10070, 18MM10127, 18MM10127A, 18MM10144, 19BM06673, 19BM16061, 19BM16064, 19BM16066, 19BM16067, 19BM16068, 19CM04082, 19CM04084, 19CM08204, 19CM08206, 19CM08207, 19CM08209, 19CM08211, 19CM19656, 19CM19658, 19CM19658A, 19CM19703, 19CM19765, 19CM19769, 19CM19838, 19CM19838A, 19CM19839, 19CM19843, 19DM05672, 18FM16504, 18FM16506, 18LM10415, 19CM08208, 19CM19760, 19EM09578, 19EM09588, 19EM09588A, 18KM04390 71332256, Lot Numbers: 18GM07672, 18MM07589, 18MM07599, 18MM07622, 19BM12639, 18FM11173, 18FM11177, 18GM16978, 18MM07597, 19BM12636, 19EM09583, 18MM07597A 71332258, Lot Numbers: 18EM23223, 18FM02458, 18GM09584, 18GM16981, 18GM18527, 18GM18527B, 18GM18527C, 19CM11413, 19EM03998, 19EM03999, 18EM23220, 18LM17983, 18LM17984, 19BM07201, 19BM07202, 19BM07214, 19CM11417, 19DM12931, 19DM12936, 19EM04000, 19EM04001, 19CM11417A 71332260, Lot Numbers: 18HM08736, 18HM16488, 18FM02468, 8FM02468B, 18FM21552, 18HM19141, 18HM16487, 18HM16487A 71332262, Lot Numbers: 19EM11295, 19EM11296,…
FDA’s list runs to 2,040 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide
These words name no state.
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Apr 22, 2020.
- FDA classified it on Jun 9, 2020.
- FDA’s Enforcement Report published it on Jun 17, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Smith & Nephew, Inc., of Memphis, TN.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 2,040 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.