Recalls for Tray, Surgical, Instrument

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.

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.

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.

The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.

The firm discovered that the current Personal Tibial/General Fixed Bracket Trays may not have the specific geometry to accommodate the tibial drill and stop guide with proper position/orientation. The drill bracket and drill guide are not the correct geometry to allow for a proper fit in the Persona Fixed Case Kit which could lead to improper sterilization of the tibial drill and stop guide.

Non-toxic inks, used on the silk screen graphics of the case bases and lids, and caddy lids, were found to be either delaminating or running off from the substrate after repeated washing and sterilization cycles.

Difficulty removing screws from the Invue caddies.

Two sections that are designated for the 8mm and 9mm screws were switched; the holes that hold the 8mm screws are designed for 9mm screws, and the holes that hold the 9mm screws are designated for 8mm screws.

The S-LIFT Instrument Case contained a bracket with peeling nylon coating.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

The firm has determined that there is a possibility that packaging seals may be compromised. The issue could result in an injury to the patient due to product contamination or loss of sterility condition.

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

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

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

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.

Lack of an adequate sterilization validation.

Lack of an adequate sterilization validation.

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.