Recall archive / FDA device enforcement
Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LE... — FDA record Z-1673-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 2, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Insert, Part Numbers: a) REF 1-10013-109, SIZE 1-LEFT MED, 9MM; b) REF 1-10013-110, SIZE 1-LEFT MED, 10MM; c) REF 1-10013-111, SIZE 1-LEFT MED, 11MM; d) REF 1-10013-113, SIZE 1-LEFT MED, 13MM; e) REF 1-10013-159, SIZE 1-RIGHT MED, 9MM; f) REF 1-10013-160, SIZE 1-RIGHT MED, 10MM; g) REF 1-10013-161, SIZE 1-RIGHT MED, 11MM; h) REF 1-10013-163, SIZE 1-RIGHT MED, 13MM; i) REF 1-10013-209, SIZE 2-LEFT MED, 9MM; j) REF 1-10013-210, SIZE 2-LEFT MED, 10MM; k) REF 1-10013-211, SIZE 2-LEFT MED, 11MM; l) REF 1-10013-213, SIZE 2-LEFT MED, 13MM; m) REF 1-10013-259, SIZE 2-RIGHT MED, 9MM; n) REF 1-10013-260, SIZE 2-RIGHT MED, 10MM; o) REF 1-10013-261, SIZE 2-RIGHT MED, 11MM; p) REF 1-10013-263, SIZE 2-RIGHT MED, 13MM; q) REF 1-10013-309, SIZE 3-LEFT MED, 9MM; r) REF 1-10013-310, SIZE 3-LEFT MED, 10MM; s) REF 1-10013-311, SIZE 3-LEFT MED, 11MM; t) REF 1-10013-313, SIZE 3-LEFT MED, 13MM; u) REF 1-10013-359, SIZE 3-RIGHT MED, 9MM; v) REF 1-10013-360, SIZE 3-RIGHT MED, 10MM; w) REF 1-10013-361, SIZE 3-RIGHT MED, 11MM; x) REF 1-10013-363, SIZE 3-RIGHT MED, 13MM; y) REF 1-10013-409, SIZE 4-LEFT MED, 9MM; z) REF 1-10013-410, SIZE 4-LEFT MED, 10MM; aa) REF 1-10013-411, SIZE 4-LEFT MED, 11MM; bb) REF 1-10013-413, SIZE 4-LEFT MED, 13MM; cc) REF 1-10013-459, SIZE 4-RIGHT MED, 9MM; dd) REF 1-10013-460, SIZE 4-RIGHT MED, 10MM; ee) REF 1-10013-461, SIZE 4-RIGHT MED, 11MM; ff) REF 1-10013-463, SIZE 4-RIGHT MED, 13MM; gg) REF 1-10013-509, SIZE 5-LEFT MED, 9MM; hh) REF 1-10013-510, SIZE 5-LEFT MED, 10MM; ii) REF 1-10013-511, SIZE 5-LEFT MED, 11MM; jj) REF 1-10013-513, SIZE 5-LEFT MED, 13MM; kk) REF 1-10013-559, SIZE 5-RIGHT MED, 9MM; ll) REF 1-10013-560, SIZE 5-RIGHT MED, 10MM; mm) REF 1-10013-561, SIZE 5-RIGHT MED, 11MM; nn) REF 1-10013-563, SIZE 5-RIGHT MED, 13MM; oo) REF 1-10013-609, SIZE 6-LEFT MED, 9MM; pp) REF 1-10013-610, SIZE 6-LEFT MED, 10MM; qq) REF 1-10013-611, SIZE 6-LEFT MED, 11MM; rr) REF 1-10013-613, SIZE 6-LEFT MED, 13MM; ss) REF 1-10013-659, SIZE 6-RIGHT MED, 9MM; tt) REF 1-10013-660, SIZE 6-RIGHT MED, 10MM; uu) REF 1-10013-661, SIZE 6-RIGHT MED, 11MM; vv) REF 1-10013-663, SIZE 6-RIGHT MED, 13MM; Unicondylar knee prothesis
- Reason
- Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an outlier versus the state of the art with respect to the risk for revision.
- Classification
- Class II
- Recalling firm
- Smith & Nephew, Inc.
- Quantity
- 7531 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1673-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) REF 1-10013-109, UDI/DI 885556873236; b) REF 1-10013-110, UDI/DI 885556873243; c) REF 1-10013-111, UDI/DI 885556873250; d) REF 1-10013-113, UDI/DI 885556873267; e) REF 1-10013-159, UDI/DI 885556873274; f) REF 1-10013-160, UDI/DI 885556873281; g) REF 1-10013-161, UDI/DI 885556873298; h) REF 1-10013-163, UDI/DI 885556873304; i) REF 1-10013-209, UDI/DI 885556873311; j) REF 1-10013-210, UDI/DI 885556873328; k) REF 1-10013-211, UDI/DI 885556873335; l) REF 1-10013-213, UDI/DI 885556873342; m) REF 1-10013-259, UDI/DI 885556873359; n) REF 1-10013-260, UDI/DI 885556873366; o) REF 1-10013-261, UDI/DI 885556873373; p) REF 1-10013-263, UDI/DI 885556873380; q) REF 1-10013-309, UDI/DI 885556873397; r) REF 1-10013-310, UDI/DI 885556873403; s) REF 1-10013-311, UDI/DI 885556873410; t) REF 1-10013-313, UDI/DI 885556873427; u) REF 1-10013-359, UDI/DI 885556873434; v) REF 1-10013-360, UDI/DI 885556873441; w) REF 1-10013-361, UDI/DI 885556873458; x) REF 1-10013-363, UDI/DI 885556873465; y) REF 1-10013-409, UDI/DI 885556873472; z) REF 1-10013-410, UDI/DI 885556873489; aa) REF 1-10013-411, UDI/DI 885556873502; bb) REF 1-10013-413, UDI/DI 885556873519; cc) REF 1-10013-459, UDI/DI 885556873526; dd) REF 1-10013-460, UDI/DI 885556873564; ee) REF 1-10013-461, UDI/DI 885556873601; ff) REF 1-10013-463, UDI/DI 885556873649; gg) REF 1-10013-509, UDI/DI 885556873670; hh) REF 1-10013-510, UDI/DI 885556873717; ii) REF 1-10013-511, UDI/DI 885556873762; jj) REF 1-10013-513, UDI/DI 885556873816; kk) REF 1-10013-559, UDI/DI 885556873854; ll) REF 1-10013-560, UDI/DI 885556873892; mm) REF 1-10013-561, UDI/DI 885556873939; nn) REF 1-10013-563, UDI/DI 885556873984; oo) REF 1-10013-609, UDI/DI 885556874028; pp) REF 1-10013-610, UDI/DI 885556874059; qq) REF 1-10013-611, UDI/DI 885556874097; rr) REF 1-10013-613, UDI/DI 885556874134; ss) REF 1-10013-659, UDI/DI 885556874196; tt) REF 1-10013-660, UDI/DI 885556874233; uu) REF 1-10013-661, UDI/DI 885556874288; vv) REF 1-10013-663, UDI/DI 885556874318; ALL BATCHES |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Nationwide distribution.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jun 7, 2023
- Recall initiation date
- May 2, 2023
- Center classification date
- May 31, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.