Hi all,
Looking for a bit of help here, we manufacture implantable hip stems and other orthopaedic devices. We recently had a batch of stems (e.g LOT 123456) which had an issue in the field where some sort of glue substance was discovered on them at the hospitals. These stems came back and were reworked and went back out to the field with a new label (and LOT 456789), however the laser marked LOT code (still 123456) was not removed so there is a discrepancy between the label and the etching on the stem.
Is there any regulatory requirement here which does not permit this?
From what I can see FDA and ISO 13485 state you must have appropriate identification and traceability in the event of recall etc. The new LOT 456789 that went out is traceable back to the original LOT 123456, and in the event of recall both LOTs would likely be recalled to be safe.
Looking for a bit of help here, we manufacture implantable hip stems and other orthopaedic devices. We recently had a batch of stems (e.g LOT 123456) which had an issue in the field where some sort of glue substance was discovered on them at the hospitals. These stems came back and were reworked and went back out to the field with a new label (and LOT 456789), however the laser marked LOT code (still 123456) was not removed so there is a discrepancy between the label and the etching on the stem.
Is there any regulatory requirement here which does not permit this?
From what I can see FDA and ISO 13485 state you must have appropriate identification and traceability in the event of recall etc. The new LOT 456789 that went out is traceable back to the original LOT 123456, and in the event of recall both LOTs would likely be recalled to be safe.
