rHead Lateral Stem, Size 1, Do Not Reuse, Sterile. Intended for replacement of the proximal end of the radius.
Check against the official notice below — it lists the full affected range.
Stryker Howmedica Osteonics Corp. is recalling approximately 16,992 radial implant components used in elbow replacement surgery, including rHead, uHead, Sigmoid Notch, Remotion, and Radio Capitellum devices in various sizes. The recall affects devices distributed worldwide across multiple lot numbers. The reason for the recall is that the sterile packaging (KIT I packaging type) may have compromised integrity due to damage that could occur during transportation, which could affect the sterile barrier protecting these implants.
The recall affects specific part numbers (310-0000 through 310-0008 and others) with numerous associated lot numbers. The source document does not specify what remedy is available to consumers who may have received or been implanted with these devices.
Written by software from the official notice below. Not reviewed by a lawyer.
Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation.
Reason for recall: Stryker is recalling rHead, uHead, Sigmoid Notch, Remotion, Radio Capitellum because packaging integrity (sterile barrier) of the packaging type KIT I may potentially be compromised by transportation. Distribution: Worldwide Distribution. Quantity: 16992 total Lot/code info: Part Number: 310-0000 (Lateral Assembly, Radial Implant, Size 1) Lot #'s 22288301, 22890701, 23424401, 23916901, 19058-S2, 19452-S2, 19661-S2, 19662-S2, 19712-S2, 19736-S2 and 19841-S2; Part Number: 310-0001 (Lateral Assembly, Radial Implant, Size 2) Lot #'s 22629201, 22890801, 23424501, 23917001, 19453-S2, 19737-S2, 19765-S2, 19766-S2 and 19793-S2; Part Number:310-0002 (Lateral Assembly, Radial Stem Implant, Size 3) Lot #'s 22288401, 22629301, 23198901, 23434601, 23917101, 19678-S2, 19767-S2, 19768-S2, 19794-S2 and 19842-S2; Part Number: 310-0003 (Lateral Assembly, Radial Implant, Size 4) Lot #'s 22288501, 23199001, 23424701, 23917201, 19068-S2, 19679-S2, 19713-S2, 19738-S2, 19795-S2 and 19843-S2; Part Number: 310-0004 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size1) Lot #'s 22288601, 23424801, 19057-S2, 19067-S2, 19454-S2, 19739-S2, 19796-S2 and 19844-S2; Part Number: 310-0005 (Lat Assembly, Rad Stem Implant, Collar 6mm, Size 2) Lot #'s 23424901, 23917301, 19063-S2, 19124-S2, 19455-S2, 19714-S2, 19740-S2 and 19797-S2; Part Number: 310-0006 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 3) Lot #'s 23199101, 23425001, 19059-S2, 19680-S2, 19741-S2, 19798-S2 and 19845-S2; Part Number: 310-0007 (Lat Assembly, Rad Stem Implant, Collar 6mm, size 4) Lot #"s 22890901, 2345101, 19060-S2, 19125-S2 and 19457-S2; Part Number: 310-0008 (Lateral Assembly, Radial Head Implant, Size 2) Lot #'s 22288701, 22629401, 22891001, 23199201, 23425201 and 23917401; Part Number:(Lateral Assembly
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.