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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer

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  Class 2 Device Recall Zimmer see related information
Date Initiated by Firm January 11, 2016
Date Posted March 12, 2016
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1154-2016
Recall Event ID 72900
510(K)Number K111447  
Product Classification Screw, fixation, bone - Product Code HWC
Product 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.
Code Information lot no.: 62127759 62196525 61955423 62289877 62052696 62052696N 62144719 61930078 62138079 62052697 61960862 62253596 62253596N 62027415 62052698 62052699 61567438 61966260 61966261 61966262 61966263 61966264 61966265 61641810 61903337 61903338 61898112 62138080 61903334 61903335 61903336 61966254 
Recalling Firm/
Manufacturer		 Zimmer Manufacturing B.V.
Turpeaux Industrial Park Rd 1 km 123.4
Mercedita PR 00715
For Additional Information Contact Consumer Relations Call Center
800-447-5633
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Packaging
Action Zimmer Biomet sent an Urgent Medical Device Recall Letter, dated January 11, 2016, to Distributors, Sales Representatives, Operation Managers, and Risk Managers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to 1.Review the notification and ensure that relevant personnel are aware of the contents. 2. Assist your Zimmer Biomet sales representative with the quarantine of any affected product. 3. Your Zimmer Biomet sales representative will remove the recalled product from your facility. 4. Complete and return the attached Certificate of Acknowledgment form to corporatequality.postmarket@zimmerbiomet.com. 5. If after reviewing this notification you have further questions or concerns please call Customer Service at 1-800-348-2759, or contact your Zimmer Biomet Sales Representative.
Quantity in Commerce 56
Distribution US Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ZIMMER INC.
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