PROXIMATE Skin Stapler. PROXIMATE RH Rotating-Head Skin Stapler (Model PRR35), PROXIMATE PX Fixed-Head Skin Stapler (Mod

FDA device recall Z-2610-2014 · posted 2014-09-08 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

The device may have a non-conforming component that may cause the device to fire an unformed staple.

Action taken

The firm, Ethicon Endo-Surgery, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated August 25, 2014 to its customers via overnight, UPS to allow tracking of the receipt. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine your inventory to determine if you have recalled product on hand; remove the recalled product and communicate the issue to relevent staff; complete and return Business Reply Form (BRF) confirming receipt of this notice within three (3) business days, indicating whether they have affected product, how much and whether they will/have returned the product or whether they no longer have any of the recall product. The BRF may be sent to Stericycle by fax at 1-855-328-6659 or by email at ethicon3022@stericycle.com. Product replacement is available for customers who return unopened affected product. If you need clinical or product support, please contact your local sales representative or call our Customer Support Center at 1-877-ETHICON (1-877-384-4266). If you need additional shipping labels or a communications package, contact Stericycle at 1-855-328-0398 and reference Event 3022.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GAG

Quantity affected

42,798

Distribution

Worldwide Distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA,

Date initiated

2014-08-12

Date posted

2014-09-08

Date terminated

2015-07-10

Location

Blue Ash, OH