Smith & Nephew, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1672-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Smith&Nephew ENGAGE Cementless Partial Knee System, Coated Tibial Tray, Part Numbers: a) REF 1-10012-100, SIZE 1-LEFT MEDIAL; b) REF 1-10012-150, SIZE 1-RIGHT MEDIAL; c) REF 1-10012-200, SIZE 2-LEFT MEDIAL; d) REF 1-10012-250, SIZE 2-RIGHT MEDIAL; e) REF 1-10012-300, SIZE 3-LEFT MEDIAL; f) REF 1-10012-350, SIZE 3-RIGHT MEDIAL; g) REF 1-10012-400, SIZE 4-LEFT MEDIAL; h) REF 1-10012-450, SIZE 4-RIGHT MEDIAL; i) REF 1-10012-500, SIZE 5-LEFT MEDIAL; j) REF 1-10012-550, SIZE 5-RIGHT MEDIAL; k) REF 1-10012-600, SIZE 6-LEFT MEDIAL; l) REF 1-10012-650, SIZE 6-RIGHT MEDIAL; Unicondylar knee prothesis

Product Classification:

Class II

Date Initiated: May 2, 2023

Date Posted: June 7, 2023

Recall Number: Z-1672-2023

Event ID: 92286

Reason for Recall:

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.

Status: Ongoing

Product Quantity: 2146 units

Code Information:

a) REF 1-10012-100, UDI/DI 00885556873113; b) REF 1-10012-150, UDI/DI 00885556873120; c) REF 1-10012-200, UDI/DI 00885556873137; d) REF 1-10012-250, UDI/DI 00885556873144; e) REF 1-10012-300, UDI/DI 00885556873151; f) REF 1-10012-350, UDI/DI 00885556873168; g) REF 1-10012-400, UDI/DI 00885556873175; h) REF 1-10012-450, UDI/DI 00885556873182; i) REF 1-10012-500, UDI/DI 00885556873199; j) REF 1-10012-550, UDI/DI 00885556873205; k) REF 1-10012-600, UDI/DI 00885556873212; l) REF 1-10012-650, UDI/DI 00885556873229; ALL BATCHES

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated