Zimmer Biomet Universal Locking Plates Sterile, Item Nos. 47492800207 47492800303 recall — FDA Z-0312-2020
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Complete FDA and NHTSA recall records dated in 2019, organized for browsing by month, category and recalling company.
Select a month to review the recall records reported during that period.
Records are ordered by the best available source date.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Limited access to flow settings as a result of the control knob having been rotated beyond its functional range
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
One lot of "Low Level Output Cable - Interface to Philips Monitor" was received from the supplier with an incorrect cable in the packaging.
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS…
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Users may experience intermittent slide dispense issues with some cartridges due to the anti-backup platen failing to advance inside the cartridge.
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
There is a possible assembly error on Autoject EI, lot number V14. This lot was packed into two products: AJ 1310, lot number V14 and AN 3310VET (branded as Petfine Auto Injector), batches…
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The seal formed on the edge of the pouch may be incomplete, which could result in a loss of sterility to the product.
Device vented gas below the stated pressure.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
Communication error alarms may result in interruption of therapy, delay in therapy, or blood loss due to non-restitution of blood in the extracorporeal circuit.
The assigned value for Rheumatoid Factor over recovers against the reference material RF serum, 1st British standard from NIBSC. Ref = 64/002. The calibrator values have been adjusted to…
Component was not tested by the supplier for adventitious agents
This archive groups records by their reported or recall date. It does not imply that every recall was initiated, announced and resolved during the same calendar year. Open the individual record for the exact dates and source details supplied by FDA or NHTSA.