The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-0612-2020·Announced 2021-02-03

Enztec Femoral Impactor Recall Due to Arm Fracture Risk

Enztec Limited is recalling 312 femoral impactors used with the DJO EMPOWR 3D KNEE system because the arm may fracture during use, potentially causing surgical delays or inflammatory responses.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of injury requiring revision surgery, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.

Plain-English summary

Enztec Limited is recalling 312 units of the REF 800-05-035 ENZTEC FEMORAL IMPACTOR - DJO. These instruments are intended to be used only with the DJO EMPOWR 3D KNEE system. The recall covers specific lots distributed between June 2016 and June 2017, with distribution limited to California.

The recall is being issued because the femoral impactors have a higher than normal risk of the arm breaking. During the impaction process, the tip of the arm may fracture and separate from the instrument. This failure may cause a minor delay in surgery. If the fractured part is not retrieved, it may cause an inflammatory response that may require revision surgery.

Healthcare providers and facilities that have received these specific lots should stop using the affected instruments and contact Enztec Limited for further instructions on retrieval or replacement.

The recalled product

Product
REF 800-05-035, ENZTEC FEMORAL IMPACTOR - DJO, (01) 09421028110624 (10) 999999, To be used only with DJO EMPOWR 3D KNEE
Manufacturer
Enztec Limited
Category
Medical Device — Surgical Instrument
Hazard
Affected units
312

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot number Distribution Date: 161471 08-Jun-16
  • 161472 08-Jun-16
  • 161473 08-Jun-16
  • 161474 08-Jun-16
  • 161475 08-Jun-16
  • 161476 08-Jun-16
  • 161477 08-Jun-16
  • 161756 29-Jun-16
  • 161757 29-Jun-16
  • 161758 29-Jun-16
  • 161759 29-Jun-16
  • 161760 29-Jun-16
  • 161761 29-Jun-16
  • 161762 29-Jun-16
  • 161822 22-Jul-16
  • 161823 22-Jul-16
  • 161824 22-Jul-16
  • 161825 22-Jul-16
  • 161826 22-Jul-16
  • 161827 22-Jul-16

Distribution

Distributed in 1 state:

Related recalls

Same hazard · fracture

See all →

Similar recalls