CLASS II ONGOING Device recall · Reported 17 Jun 2020 · FDA Enforcement Report
R3 Zero Hole Ha Coated Hemispherical Stiktite Coated Shell recalled
Smith & Nephew is recalling smith&nephew R3 Zero Hole HA Coated Hemispherical Stiktite Coated Shell. The recall was initiated on 22 Apr 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2332-2020
- FDA event ID
- 85637
- Recalling firm
- Smith & Nephew, Memphis, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 22 Apr 2020
- FDA classified
- 9 Jun 2020
- Reported
- 17 Jun 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Device type
- Hip & Knee Implants
Timeline
| 22 Apr 2020 | Recall initiated by company | |
| 9 Jun 2020 | Classified by FDA | +48 days |
| 17 Jun 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Worldwide
Questions about this recall
Is R3 Zero Hole Ha Coated Hemispherical Stiktite Coated Shell recalled?
Yes. Smith & Nephew recalled R3 Zero Hole Ha Coated Hemispherical Stiktite Coated Shell on 22 Apr 2020. The recall is Class II and its status is Ongoing. Recall number Z-2332-2020.
Why was it recalled?
A manufacturing error resulted in out of specification R3 Acetabular Shells
Which lots are affected?
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, 18MM02014 71332264, Lot Numbers: 19EM17718
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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