Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

FDA device recall Z-1619-2023 · posted 2023-05-23 · Open, Classified

Recall details

Recalling firm

Windstone Medical Packaging, Inc.

Reason for recall

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Action taken

On April 24, 2023, Aligned Medical Solutions issued a "Urgent: Medical Device Recall" notification via E-Mail. Customers were asked to take the following actions: 1. Immediately check your inventory for the voluntary recalled products listed above and place them under quarantine. 2. Due to the manufacturing process any finished sterilized packs remaining in inventory, or at your facility will require over labeling for the all products affected by this recall. Packs will be labeled with a sticker attached to each pack. 3. Complete the attached Recall Reply Form listing all inventory of affected product by lot number and quantity 4. If you have further distributed this products, please identify your distribution partners, and notify them at once of the product recall. Your notification to your customers should include a copy of this notification letter. 5. Please complete the Recall Reply Form within 5 business days and return via email to vdavis@alignedmedicalsolutions.com even if you have no affected product on hand. 6. Indicate on the Recall Reply Form if a replacement STERIS product is needed. 7. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Root cause

Unknown/Undetermined by firm

Status

Open, Classified

Product code

KDD

Quantity affected

30 kits

Distribution

US: MA OUS: None

Date initiated

2023-04-24

Date posted

2023-05-23

Location

Billings, MT