The Recall Desk
HighFDA (Devices)·Z-1019-2019·Announced 2019-03-27

AAP Implantate Lambotte Chisel Recalled for Potential Breakage at Welded Parts

AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel due to a potential risk of breaking at the welded piece parts of the chisel body and knocking plate.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect in a surgical instrument that could break during use. Per the rubric, risk-of-harm products where injury has not yet been reported are rated as High.

Plain-English summary

AAP Implantate AG is recalling 25 units of the 20 mm Lambotte chisel, reference number IU 3000-20. The affected units are identified by lot numbers I011, I012, I013, I014, I015, I016, and I017. These surgical instruments are intended to aid in the insertion of bone plates and screws, as well as for reduction and support during orthopedic surgeries.

The recall was initiated because there is a potential for the Lambotte chisel to break at the welded piece parts of the chisel body and knocking plate. The agency has classified this recall as Class II.

The affected products were distributed worldwide, specifically in the United States (nationwide, with specific mention of the state of Texas) and in Germany. Consumers and healthcare providers should stop using the affected instruments and contact the recalling firm for further instructions.

The recalled product

Product
aap Implante AG, Lambotte chisel, 20 mm, REF IU 3000-20 Product Usage: Surgical instruments are intended to aid in the insertion of bone plates and screws as well as for reduction and support during orthopedic surgeries. If not otherwise specified, instruments are intended fo
Manufacturer
AAP Implantate Ag
Category
Medical Device — Surgical Instruments
Hazard
Affected units
25

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 (7)

  • Lot Numbers: I011
  • I012
  • I013
  • I014
  • I015
  • I016
  • I017

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same manufacturer · AAP Implantate Ag

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Same hazard · structural failure

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