Ortho Development Corporation

Complete recall history across all FDA and CPSC categories — 8 total recalls

Ortho Development Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (8)

FDA medical device enforcement actions by Ortho Development Corporation

Date Product Reason Class
May 30, 2019 Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. The locking mechanism of the tibial tray exhibited a manufacturing defect i... Class II
May 30, 2019 Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. The locking mechanism of the tibial tray exhibited a manufacturing defect i... Class II
Jul 11, 2014 Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA ... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial ... Class II
Jul 11, 2014 Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial ... Class II
Jul 11, 2014 PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TK... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial ... Class II
Jul 11, 2014 Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial ... Class II
Jul 11, 2014 Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE... Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial ... Class II
Apr 1, 2014 PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balan... A femoral component containing pegs was found in a box for the pegless version. Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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