{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "status": "Terminated", "city": "Mercedita", "state": "PR", "country": "United States", "classification": "Class II", "openfda": {}, "product_type": "Devices", "event_id": "72900", "recalling_firm": "Zimmer Manufacturing B.V.", "address_1": "Turpeaux Industrial Park Rd 1 km 123.4", "address_2": "", "postal_code": "00715", "voluntary_mandated": "Voluntary: Firm initiated", "initial_firm_notification": "Letter", "distribution_pattern": "US Nationwide Distribution", "recall_number": "Z-1130-2016", "product_description": "Product 32 consists of all product under product code: HWC and same usage: Item no:\t 47115401200\tHERBERT BONE SCREW, 3.0MM 47115401400\tHERBERT BONE SCREW, 3.0MM 47115401600\tHERBERT BONE SCREW, 3.0MM 47115401800\tHERBERT BONE SCREW, 3.0MM 47115402000\tHERBERT BONE SCREW, 3.0MM 47115402200\tHERBERT BONE SCREW, 3.0MM 47115402400\tHERBERT BONE SCREW, 3.0MM 47115402600\tHERBERT BONE SCREW, 3.0MM 47115402800\tHERBERT BONE SCREW, 3.0MM 47115403000\tHERBERT BONE SCREW, 3.0MM 47115502505\tHERBERT CANNULATED BONE S 47115503005\tHERBERT CANNULATED BONE S 47115503505\tHERBERT CANNULATED BONE S 47115504005\tHERBERT CANNULATED BONE S 47115504007\tHERBERT CANNULATED BONE S 47115504505\tHERBERT CANNULATED BONE S 47115504507\tHERBERT CANNULATED BONE S 47115505005\tHERBERT CANNULATED BONE S 47115505007\tHERBERT CANNULATED BONE S 47115505505\tHERBERT CANNULATED BONE S 47115505507\tHERBERT CANNULATED BONE S 47115506005\tHERBERT CANNULATED BONE S 47115506007\tHERBERT CANNULATED BONE S 47115506505\tHERBERT CANNULATED BONE S 47115506507\tHERBERT CANNULATED BONE S 47115507005\tHERBERT CANNULATED BONE S 47115507007\tHERBERT CANNULATED BONE S 47115507505\tHERBERT CANNULATED BONE S 47115507507\tHERBERT CANNULATED BONE S 47115508005\tHERBERT CANNULATED BONE S 47115508007\tHERBERT CANNULATED BONE S 47115508505\tHERBERT CANNULATED BONE S 47115508507\tHERBERT CANNULATED BONE S 47115509005\tHERBERT CANNULATED BONE S 47115509007\tHERBERT CANNULATED BONE S 47115509505\tHERBERT CANNULATED BONE S 47115509507\tHERBERT CANNULATED BONE S 47115510005\tHERBERT CANNULATED BONE S 47115510007\tHERBERT CANNULATED BONE S 115001000\tHERBERT MINI BONE SCREW 2 115001200\tHERBERT MINI BONE SCREW 2 115001400\tHERBERT MINI BONE SCREW 2 115001600\tHERBERT MINI BONE SCREW 2 115001800\tHERBERT MINI BONE SCREW 2 115002000\tHERBERT MINI BONE SCREW 2 115002200\tHERBERT MINI BONE SCREW 2 115002400\tHERBERT MINI BONE SCREW 2 115201200\tHERBERT/WHIPPLE CANN BONE 115201400\tHERBERT/WHIPPLE CANN BONE 115201600\tHERBERT/WHIPPLE CANN BONE 115201800\tHERBERT/WHIPPLE CANN BONE 115202000\tHERBERT/WHIPPLE CANN BONE 115202200\tHERBERT/WHIPPLE CANN BONE 115202400\tHERBERT/WHIPPLE CANN BONE 115202600\tHERBERT/WHIPPLE CANN BONE 115202800\tHERBERT/WHIPPLE CANN BONE 115203000\tHERBERT/WHIPPLE CANN BONE Product 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.", "product_quantity": "4018", "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. 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