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Recall Observatory FDA recall evidence

Device product

Smith & Nephew GENESIS(R) II/LEGION(TM) PATELLAR COMPONENT, RESURFACING ROUND, 32MM STANDARD, FOR CEMENTED USE ONLY WITH JOURNEY PEG, STERILE EO, Rx only, REF Number: 71934490 knee implant.

Z-0573-2016

November 09, 2015

Class II

Product summary

Firm
Smith & Nephew, Inc.
Event
Event 72866
Status
Terminated
Classification
Class II
Quantity
20 units
Official record key
device-enforcement:Z-0573-2016

Official wording

Reason: One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.

Code information: Batch # 15GM07831

Distribution pattern: US Distribution to states of:FL, MO, IN and TX.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    One lot of 35 mm patella implants is labeled as 32 mm. These implants have pegs which are spaced proportionally; therefore the mismatch prevents the pegs from properly aligning with pre-drilled holes during implantation.