Recall record at a glance
| Official record | Z-1163-2016 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Zimmer Manufacturing B.V. |
| Report date | Mar 23, 2016 |
| Recall initiation date | Jan 11, 2016 |
| Quantity | 5538 |
| Location | Mercedita, PR, United States |
Official product description
Product 65 consists of all product under product code: KTT and same usage: Item no: 119413594 VERSA-FX II KEYLESS SHORT 119413595 VERSA-FX II KEYLESS SHORT 119413596 VERSA-FX II KEYLESS SHORT 119413004 VERSA-FX II KEYLESS TUBE 119413005 VERSA-FX II KEYLESS TUBE 119413006 VERSA-FX II KEYLESS TUBE 119413008 VERSA-FX II KEYLESS TUBE 119413504 VERSA-FX II KEYLESS TUBE 119413505 VERSA-FX II KEYLESS TUBE 119413506 VERSA-FX II KEYLESS TUBE 119413508 VERSA-FX II KEYLESS TUBE 119414004 VERSA-FX II KEYLESS TUBE 119414005 VERSA-FX II KEYLESS TUBE 119414006 VERSA-FX II KEYLESS TUBE 119414008 VERSA-FX II KEYLESS TUBE 119414504 VERSA-FX II KEYLESS TUBE 119414506 VERSA-FX II KEYLESS TUBE 119414508 VERSA-FX II KEYLESS TUBE 119415004 VERSA-FX II KEYLESS TUBE 119415005 VERSA-FX II KEYLESS TUBE 119415006 VERSA-FX II KEYLESS TUBE 119415008 VERSA-FX II KEYLESS TUBE 119313094 VERSA-FX II SHORT TUBE PL 119313095 VERSA-FX II SHORT TUBE PL 119313096 VERSA-FX II SHORT TUBE PL 119313594 VERSA-FX II SHORT TUBE PL 119313595 VERSA-FX II SHORT TUBE PL 119313596 VERSA-FX II SHORT TUBE PL 119314094 VERSA-FX II SHORT TUBE PL 119314594 VERSA-FX II SHORT TUBE PL 119314595 VERSA-FX II SHORT TUBE PL 119315094 VERSA-FX II SHORT TUBE PL 119315095 VERSA-FX II SHORT TUBE PL 119313002 VERSA-FX II STD TUBE PLAT 119313003 VERSA-FX II STD TUBE PLAT 119313004 VERSA-FX II STD TUBE PLAT 119313005 VERSA-FX II STD TUBE PLAT 119313006 VERSA-FX II STD TUBE PLAT 119313008 VERSA-FX II STD TUBE PLAT 119313010 VERSA-FX II STD TUBE PLAT 119313012 VERSA-FX II STD TUBE PLAT 119313502 VERSA-FX II STD TUBE PLAT 119313503 VERSA-FX II STD TUBE PLAT 119313504 VERSA-FX II STD TUBE PLAT 119313505 VERSA-FX II STD TUBE PLAT 119313506 VERSA-FX II STD TUBE PLAT 119313508 VERSA-FX II STD TUBE PLAT 119313510 VERSA-FX II STD TUBE PLAT 119313512 VERSA-FX II STD TUBE PLAT 119314002 VERSA-FX II STD TUBE PLAT 119314003 VERSA-FX II STD TUBE PLAT 119314004 VERSA-FX II STD TUBE PLAT 119314005 VERSA-FX II STD TUBE PLAT 119314006 VERSA-FX II STD TUBE PLAT 119314502 VERSA-FX II STD TUBE PLAT 119314503 VERSA-FX II STD TUBE PLAT 119314504 VERSA-FX II STD TUBE PLAT 119314505 VERSA-FX II STD TUBE PLAT 119314506 VERSA-FX II STD TUBE PLAT 119314510 VERSA-FX II STD TUBE PLAT 119314512 VERSA-FX II STD TUBE PLAT 119315003 VERSA-FX II STD TUBE PLAT 119315004 VERSA-FX II STD TUBE PLAT 119315005 VERSA-FX II STD TUBE PLAT 119315006 VERSA-FX II STD TUBE PLAT 119315012 VERSA-FX II STD TUBE PLAT 119315014 VERSA-FX II STD TUBE PLAT 119315018 VERSA-FX II STD TUBE PLAT 119309008 VERSA-FX II SUPRACONDYLR 119309010 VERSA-FX II SUPRACONDYLR 119309012 VERSA-FX II SUPRACONDYLR 119309014 VERSA-FX II SUPRACONDYLR 119309506 VERSA-FX II SUPRACONDYLR 119309508 VERSA-FX II SUPRACONDYLR 119309510 VERSA-FX II SUPRACONDYLR 119309512 VERSA-FX II SUPRACONDYLR 119309514 VERSA-FX II SUPRACONDYLR 119309516 VERSA-FX II SUPRACONDYLR 119309522 VERSA-FX II SUPRACONDYLR 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.
Why the product 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.
Distribution information
US Nationwide Distribution
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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