Zimmer Manufacturing B.V. recalls Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM S…

Recall date

January 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1154-2016

FDA classification

Class II

Brand / firm

Zimmer Manufacturing B.V.

Sold / distributed

US Nationwide Distribution

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Product 56 consists of all product under product code: HWC and same usage: Item no: 47234702032 PERI SCR 3.5MM X 32MM STE 47234702018 PERI SCR. 3.5MM X 18MM ST 47234702020 PERI SCR. 3.5MM X 20MM ST 47234702022 PERI SCR. 3.5MM X 22MM ST 47234702026 PERI SCR. 3.5MM X 26MM ST 47234702030 PERI SCR. 3.5MM X 30MM ST 47234702034 PERI SCR. 3.5MM X 34MM ST 47234702036 PERI SCR. 3.5MM X 36MM ST 47234702042 PERI SCR. 3.5MM X 42MM ST 47234702046 PERI SCR. 3.5MM X 46MM ST 47234702050 PERI SCR. 3.5MM X 50MM ST 47234702080 PERI SCR. 3.5MM X 80MM ST 47234702085 PERI SCR. 3.5MM X 85MM ST 47234702155 PERI SCR. 4.0MM X 55MM 47234702160 PERI SCR. 4.0MM X 60MM 47234702210 PERI SCR. 4.0MMX10MM FULL 47234702212 PERI SCR. 4.0MMX12MM FULL 47234702214 PERI SCR. 4.0MMX14MM FULL 47234702216 PERI SCR. 4.0MMX16MM FULL 47234702260 PERI SCR. 4.0MMX60MM FULL 47234702336 PERI SCR. 4.5MM X 36MM 47234702338 PERI SCR. 4.5MM X 38MM 47234712440 PERI SCR. 6.5MM X 140MM 47234702670 PERI SCR. 6.5MM X 70MM 47234702122 PERI. SCR 4.0MM X22MM 47234702124 PERI. SCR 4.0MM X24MM 47234702126 PERI. SCR 4.0MM X26MM 47234702128 PERI. SCR 4.0MM X28MM Usage: A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.