Recall Z-2333-2020
Smith & Nephew, Inc. · initiated April 22, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 71335540, Lot Numbers: 18JM08648, 18JM08650, 18MM12391 71335542, Lot Numbers: 18HM20695, 18LM09821, 19DM12897, 19DM12898, 19DM12899 71335544, Lot Numbers: 18LM02189, 18LM02191, 18LM02192, 18MM08580, 18MM08582 71335546, Lot Numbers: 19AM10686, 19AM07909, 18MM08601, 18HM04443, 18HM04455, 18HM04461, 18HM04474, 18HM04483, 18HM04487, 18HM04488, 18HM04492, 18HM04495, 18HM04926, 18HM19845, 18HM19846, 18HM19848, 18HM19851, 18JM06297, 18JM06307, 18JM06308, 18KM17658, 18KM17659, 18KM17660, 18KM17662, 18MM08596, 18MM08602, 18MM08604, 18MM08607, 18MM08608, 18MM08609, 18MM08610, 18MM11254, 18MM11255, 19AM07907, 19AM07908, 19AM07916, 19AM07922, 18HM04443A, 18HM04455A, 18HM04488A, 18KM17662A, 19AM07922A, 18HM20664 71335548, Lot Numbers: 18LM19747, 19EM11800, 18LM13809, 18JM12746, 18KM09504, 18KM09498, 18KM09497, 19AM15831, 18LM19745, 18KM20266, 18MM14693, 18MM14703, 18MM14704, 18MM14697, 18LM13809A, 18MM01152, 18JM12746A, 18MM14703A, 18KM09502, 18LM13799, 18GM04646, 18GM04651, 18GM04658, 18GM04669, 18GM04677, 18GM04679, 18GM16200, 18GM16201, 18GM16203, 18GM16208, 18GM16210, 18GM16222, 18GM16240, 18GM18532, 18GM18541, 18GM18547, 18GM18567, 18GM18570, 18HM01688, 18HM01700, 18HM01709, 18HM01730…
Reason for recall
A manufacturing error resulted in out of specification R3 Acetabular Shells
FDA-determined cause: Process control
Action taken
The firm notified its consignees by letter (delivered by Fed Ex) and email beginning on 04/22/2020. Consignees are asked to inspect inventory, locate and quarantine affected devices. Affected product will be returned to Smith & Nephew. Questions or concerns regarding this recall may be directed to: FieldActions@smith-nephew.com.
Details
- Recall number
- Z-2333-2020
- Initiated
- April 22, 2020
- Product code
- MBL – Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous
- Quantity
- 6468 devices
- Distribution
- Worldwide
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2331-2020 Class II | smith&nephew R3 NO HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2332-2020 Class II | smith&nephew R3 ZERO HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured in…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2334-2020 Class II | smith&nephew R3 THREE HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2335-2020 Class II | smith&nephew R3 MULTI HOLE HEMISPHERICAL STIKTITE COATED SHELL, manufactured in the…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |
| Z-2336-2020 Class II | smith&nephew R3 MULTI HOLE HA COATED HEMISPHERICAL STIKTITE COATED SHELL, manufactured…A manufacturing error resulted in out of specification R3 Acetabular Shells | 04/22/2020Open, Classified |