Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Product 30 consists of all product under product code: KTT Recalled by Zimmer Manufacturing B.V. Due to As a result of the insufficient sealer calibration...

Date: January 11, 2016
Company: Zimmer Manufacturing B.V.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Zimmer Manufacturing B.V. directly.

Affected Products

Product 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 118101040 FREE-LOCK LAG SCREW, 12.7 118101042 FREE-LOCK LAG SCREW, 12.7 118101045 FREE-LOCK LAG SCREW, 12.7 118101047 FREE-LOCK LAG SCREW, 12.7 118101052 FREE-LOCK LAG SCREW, 12.7 118101055 FREE-LOCK LAG SCREW, 12.7 118101057 FREE-LOCK LAG SCREW, 12.7 118101522 FREE-LOCK LAG SCREW, 15.8 118101525 FREE-LOCK LAG SCREW, 15.8 118101527 FREE-LOCK LAG SCREW, 15.8 118101530 FREE-LOCK LAG SCREW, 15.8 118101532 FREE-LOCK LAG SCREW, 15.8 118101547 FREE-LOCK LAG SCREW, 15.8 118109010 FREE-LOCK SUPRACOND TUBE/ 118109510 FREE-LOCK SUPRACOND TUBE/ 118113005 FREE-LOCK TUBE & SCP PLAT 118113006 FREE-LOCK TUBE & SCP PLAT 118113010 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113510 FREE-LOCK TUBE & SCP PLAT 118113594 FREE-LOCK TUBE & SCP PLAT 118114005 FREE-LOCK TUBE & SCP PLAT 118114006 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114004 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114504 FREE-LOCK TUBE & SCP PLAT 118114505 FREE-LOCK TUBE & SCP PLAT 118114506 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118115004 FREE-LOCK TUBE & SCP PLAT 118115005 FREE-LOCK TUBE & SCP PLAT 118115006 FREE-LOCK TUBE & SCP PLAT 118115008 FREE-LOCK TUBE & SCP PLAT 118115094 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113004 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

Quantity: 3500

Why Was This Recalled?

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Zimmer Manufacturing B.V.

Zimmer Manufacturing B.V. has 91 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report