Tray, Surgical, Instrument（FSM）

Their is a potential that the reamer may kick or bind up during or immediately prior to use.

The protective pouches were identified to have been improperly labeled with UDI that is associated with an incorrect GMDN (Global Medical Device Nomenclature) code. These blue foam pouches were misused due to misclassification of the GMDN.

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Medline Industries, LP is recalling certain kits and trays that were manufactured using specific lots of Nurse Assist (as components): 0.9% Sodium Chloride Irrigation USP, Sterile Water for Irrigation USP and Saline Flush Syringe. Nurse Assist issued a recall due to the potential lack of sterility, which could result in the solution being non sterile.

Mislabeled: Product is marked with GTIN # 04046955299592 however; the correct GTIN # is 04046955299607.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.

Triathlon Pro Tibial Preparation Tray may have been kitted with the Triathlon Cemented #1-3 Keel Punch (P/N: 6541-2-013) instead of the Triathlon Pro #0-3 Cemented Keel Punch (P/N: 6541-2-013Y) instrument can lead to delay in surgery or if used could lead to unintended bone preparation

Lack of an adequate sterilization validation.

Lack of an adequate sterilization validation.

There is a potential for silicone shedding during cleaning and sterilization.

There is a potential for silicone shedding during cleaning and sterilization.

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

Affected screw gauges incorrectly measure screws 5.41mm shorter than the actual overall screw length.

The screw rack plate was assembled incorrectly which could cause the screws in the screw rack to sit low and touch the surface beneath the screw rack.

Covidien issued a labeling update for the Covidien Devon Light Gloves. Busse had incorporated the affected gloves in several kits and distributed them prior to receipt of the recall notification.

Stryker has become aware that the inhomogeneity of the filter paper might potentially compromise the ability of the filter to maintain a sterile barrier during post-sterilization shelf-life.

It was found through review of open Complaints and stock investigations that a single lot of Zimmer Universal Locking System 3.5 mm Stainless Steel Base and Trays has incorrect silk screening as applied by the supplier. The T-plate catalog numbers noted in the tray are listed as the 00-4946-xxx-xx series (titanium plates); however, the correct numbers should be 00-4936-xxx-xx (stainless steel plat

The wrap is for single use for nail sterilization but does not have sufficient testing for the device to be considered a multi-use item.