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.
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 3/5 (High).
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…
- Manufacturer
- AAP Implantate Ag
- 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
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