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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Synthes (USA) Products LLC: The peel pouches for the affected reaming rods and extraction hooks are delaminating.

Agency Publication Date: November 19, 2016
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Affected Products

Product: 2.5 mm Reaming Rod with Ball Tip & Extension/950 mm, Sterile

Catalog ID 351.707S, Lot Numbers: 9963694; 9963695; 9963696; 9963697; 9963698; 9963699; 9972862; H040500; H040502; H040503; H060093; H060094; H060095; H060096; H060097; H080022; H080023; H080024; H080025; H089873; H089874; H089875.

Lot Numbers:
Numbers
Product: 3.0 mm Reaming Rod/950 mm, Sterile

Catalog ID 351.71S, Lot Numbers: H000111; H033314; H067857; H067858; H069074; H069079; H087019; H090015; H090747; H100713; H123976.

Lot Numbers:
Numbers
Product: 3.0 mm Reaming Rod/950 mm w/straight Ball Tip, Sterile

Catalog ID 351.76S, Lot Numbers: 9938361; 9970591; H000103; H001021; H032765; H032769; H033313; H043056; H043057; H043058; H043551; H043564; H054931; H054932; H054933; H056192; H056193; H056194; H058374; H058375; H058376; H058377; H058378; H059426; H059427; H059428; H067852; H067853; H069071; H069073; H077277; H077452; H077704; H086318; H086319; H087018; H089848; H089849; H089850; H090012; H090013; H090014; H090745; H099607; H099608; H099610; H099611; H115889; H115890; H115891; H115892; H122535; H122998; H123001; H123002; H123970; H123975; H135276; H135277; H135278; H141083; H141085.

Lot Numbers:
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Product: 3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

Catalog ID 355.041S, Lot Numbers: H085635; H087271; H094462; H111419; H136756

Lot Numbers:
Numbers
Product: 2.5 mm Guide Rod w/Smooth Tip 950 mm, Sterile

Catalog ID 355.042S, Lot Numbers: H085634; H094463.

Lot Numbers:
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Product: Extraction Hook - Sterile for TI Cannulated Nails

Catalog ID 355.399S, Lot Numbers: H102610

Lot Numbers:
Numbers
Product: 2.5 mm TI Calibrated Reaming Rod 850 mm, Sterile

Catalog ID 359.083S, Lot Numbers: H115566; H116597; H116601; H117049

Lot Numbers:
Numbers
Product: 2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

Catalog ID 351.709S, Lot Numbers: 9913251; 9913252; 9913254; 9913256; 9913259; 9913260; 9950460; 9950461; 9950462; 9950463; 9950464; 9963747; 9963748; 9963749; 9963751; 9963752; 9963753; 9963755; 9963756; 9963757; 9985371; 9985372; 9985373; 9985374; H040508; H040509; H040510; H040511; H040512; H040517; H040518; H040519; H060103; H060104; H060105; H060106; H060107; H060108; H060114; H060115; H060116; H080034; H080035; H080036; H080037; H080038; H080039; H080040; H080041; H080081; H080082; H080083; H080084; H080085; H080086; H080087; H080088; H080089; H105527; H105528; H105529; H105530.

Lot Numbers:
Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 75502
Status: Resolved
Manufacturer: Synthes (USA) Products LLC
Manufactured In: United States
Units Affected: 8 products (1,951 units; 887 units; 5478 units; 319 units; 139 units; 114 units; 260 units; 2,157 units)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. 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. Refer to the openFDA terms of service for more information.