FDA-Device2021-02-03Class II
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Enztec Limited
Hazard
The femoral impactors have a higher than normal risk of the arm breaking. During impaction the tip of the arm may fracture and separate from the instrument. This may cause a minor delay in surgery. If not retrieved, it may cause an inflammatory response that may require revision surgery.
Sold states
CA
Affected count
312 Femoral Impactors
Manufactured in
26 Dakota Crescent, Sockburn, Christchurch, New Zealand
Products
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0612-2020Don't want to check this manually?
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